Declaration of Conformity-Addendum

Annex to the Declaration of Conformity FORM 141-04 / DCR 11-031

Document: RA DoCa-020 Rev. 05 / DCR 13-503

Climber™ Guiding Catheter Page 1 of 13

This document is the property of PendraCare International B.V. This document contains confidential information that is

not to be disclosed to unauthorized persons.

Document Release Date: 2014-01-14

Annex to the Declaration of Conformity - Supporting Information –

Annex to the “Declaration of Conformity to Directive 93/42/EEC concerning Medical Devices” for

Climber™ Guiding Catheter (RA DoC-020 Rev. 05)

Legal Manufacturer:

PendraCare International B.V., Van der Waalspark 22, 9351 VC Leek, The Netherlands.

Supporting documentation

Documentation that contains proof of compliance to the aforementioned Directive is described below and is retained under the premises of the manufacturer.

I. Technical Information

The Regulatory File (Summary of Technical Documentation / STED) 3rd

Generation Guiding Catheters, that was initially reviewed and approved by PendraCare International B.V. on December 23, 2010 demonstrates continuous compliance with the relevant essential requirements of the current Directive 93/42/EEC.

The STED is maintained and provides information with respect to changes implemented in the product and its manufacturing processes.

The documentation referenced in the STED that contains the evidence of conformity with the applicable regulations is part of the product’s “Design History File” (DHF). The product’s DHF is archived within PendraCare’s Documentation Control System at PendraCare International B.V., Van der Waalspark 22, 9351 VC Leek, The Netherlands.

To certify that the type of the products falling within the indicated product category conforms to the provisions of the current Directive 93/42/EEC in accordance with Annex II excluding (4) of the Directive, DEKRA Certification B.V. issued to PendraCare International B.V. a “CE Marking of Conformity” Certificate (2020764CE01) per current Directive 93/42/EEC, Annex II excluding (4) - Full Quality Assurance System for “Cardiovascular Catheters”.

The Declaration of Conformity for this Guiding Catheter (Class IIa) is valid in combination with the current CE Marking of Conformity Certificate.

The Declaration of Conformity is valid until the expiration date indicated on the CE Marking of Conformity Certificate.

This Declaration of Conformity covers: Product Category (collective term): Cardiovascular Catheters Generic Device Group Term: Intravascular Guiding Catheter Product type (family): Climber™ Guiding Catheter







II. Quality Management Systems

The below certificates have been issued by the indicated Notified Bodies to PendraCare International B.V. in respect of the operations (development, manufacturing, final inspection and distribution) at the indicated site and for the products mentioned in the scope of the registration.

Certificate of Registration (2086817), issued by DEKRA Certification B.V. to PendraCare International B.V. to certify that the Quality Management System complies with the relevant requirement of EN-ISO 13485: 2012 for the activities detailed in the scope of the registration.

Certificate “CE Marking of Conformity” (2020764CE01), issued by DEKRA Certification B.V. to PendraCare International B.V. to certify that the manufacturer fulfils the relevant provisions of the current Directive 93/42/EEC, Annex II excluding (4) for the indicated product category “Cardiovascular Catheters”. The necessary information and the reference to the relevant documentation of the products concerned and the assessments performed, are stated in the Certification Notice (2020764CN).

Supporting Information:

Authorized Representative European Community: Not Applicable

Notified Body: The Notified Body that assesses the conformity of PendraCare’s products and PendraCare’s Quality Management System with the requirements of the Directive 93/42/EEC is:

DEKRA Certification B.V. Meander 1051 6825 MJ Arnhem The Netherlands

DEKRA Certification B.V. P.O. Box 5185 6802 ED Arnhem The Netherlands

DEKRA Certification B.V. is part of DEKRA. DEKRA Certification B.V. is registered in Arnhem 09085396

Telephone No.: +31 88 96 83000

Web Address: www.dekra.com www.dekra-certification.com

Notified Body I.D. no: 0344 For supporting information, see the following attachments: 1. Product Characteristics 2. Indications for Use - Statement 3. Catalogue number & Lot number System 4. Device Nomenclature 5. Declaration of Conformity to applied International Standards 6. Statements / Claims

Place of issue: Leek, The Netherlands

Approved by: A. Roossien, MSc., PhD. Manager Quality Assurance & Regulatory Affairs PendraCare International B.V.

Date: 2014-01-14

http://www.dekra.com/

http://www.dekra-certification.com/







Attachment 1

Product Characteristics

Brand / Trade Name: Climber™ Guiding Catheter

Regulatory File: PendraCare’s 3rd

Generation Guiding Catheters

Indication for Use (per IFU)

The Guiding Catheter is designed to provide a pathway through which therapeutic and

diagnostic devices are introduced. The Guiding Catheter is intended to be used in the coronary or peripheral vascular system.

Contra-indication: None known.

Class:

Based on classification rule 7 (first indent; short term use) of Annex IX of the current

Directive 93/42/EEC concerning Medical Devices, the device is considered a Class lla device. [Note: the device is used in the Central Circulatory System but it does not control, diagnosis, monitor or correct a defect of the heart or a vessel belonging to the Central Circulatory System.] [Regulatory File has been reviewed & approved by the Notified Body].

Legal Manufacturer:

PendraCare International B.V., Van der Waalspark 22, 9351 VC Leek, The Netherlands. PendraCare International B.V. is part of PendraCare Holding B.V. PendraCare Holding B.V. is part of Wellinq Holding B.V. Manufacturing License Authority: Dutch Chamber of Commerce Manufacturing License Registration numbers:

PendraCare Holding B.V.: 02092853 PendraCare International B.V.: 02086018 EORI-number: NL813700917

Manufacturing Location: Country of Origin: (Final assembly)

Sterilisation location: Sterigenics Belgium SA Zoning Industriel de Petit-Rechain (Chaineux) Avenue du Parc 29, B-4800 Verviers, Belgium

Contact Person PendraCare:

A. Roossien, MSc, PhD. Manager Quality Assurance & Regulatory Affairs PendraCare International B.V. Phone: +31 594 51 07 55 / Fax: +31 594 51 07 69 e-mail: [email protected] internet: www.pendracare.com

Marketing Authorization Holder (MAH) & (Central) Distribution:

Terumo Europe N.V. Interleuvenlaan 40 3001 Leuven, Belgium

[Note: Local distribution may be organized through “local authorized distributors” as indicated in a country- and distributor-specific “Letter of Authorization” or “Power of Attorney”]

Declared by: A. Roossien, MSc., PhD. Manager Quality Assurance & Regulatory Affairs PendraCare International B.V.

Date: 2014-01-14

mailto:[email protected]

http://www.pendracare.com/







Attachment 2

Indications for Use - Statement (Description for Use Statement)

Trade name: Climber™ Guiding Catheter

Device description: The Guiding Catheter is a single use device that facilitates the passage of intravascular devices.

Indication for Use: The Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Guiding Catheter is intended to be used in the coronary or peripheral vascular system.

Contraindications: None known

Reference: Instructions for Use (Specification SPEC G1-189)

Manufacturer

PendraCare International B.V. Van der Waalspark 22 9351 VC Leek The Netherlands


Date: 2014-01-14







Attachment 3

Catalogue numbers & Lot numbers


Catalogue

Numbering

System:

Meaning of catalogue (REF) numbers:

The catalogue (REF) numbers of PendraCare’s products are composed of a unique identifier composed of an 8 digit number with the following structure: AA-BCDDEEFG, whereby:

AA = Catheter type: GC = Guiding Catheter

B = Manufacturer: P = PendraCare

C = French Size (diameter): 5 = 5F; 6 = 6F; 7 = 7F; 8 = 8F

DD = Tip-Shape Configuration: For tip shape configuration & tip shape curve see list of tip shapes (table “Shape”) EE = Shape curve:

F = Catheter Length: 0 = 100 cm

2 = 125 cm

G = Side holes: N = without side holes

A = 2 “in-line” side holes

Example: GC-P6AL070N indicates a 6F Climber Guiding Catheter. The Climber is a hydrophilic

coated guiding catheter which does not feature side holes (N). The pouch contains one catheter 100 cm in length featuring an AL.75 tip-shape.

Lot

Numbering

System:

Meaning of the LOT code:

Per PendraCare’s Quality Management System, the system used by the manufacturer to identify the manufacturing cycle is called the Device History Record (DHR). The DHR is a compilation of records containing the production history (traceability-records) of a finished device. The lot number of a PendraCare’s device (final assembly) is expressed as a 8-digit number which is hyphenated between the fourth (4

th) and fifth (5

th) number.

The meaning of the lot code # # # # - # # # # is as follows:

Numbers position #1 & #2 The year of manufacturing (13 indicates 2013)

Numbers position #3 & #4 The month of manufacturing (from 01 to 12)

Numbers position #5 thru #8 A non-repeated, sequential (unique) number starting from 0001. At the start of each month, the sequential number starts again from 0001.

Example: On the label “LOT 1305-1234” indicates the 1234th lot manufactured in May 2013.

Lot numbers: This Declaration of Conformity applies to the following lot number: LOT 1305-0213 and beyond


Date: 2014-01-14







Catalogue numbers (I)

Device Name: Climber™ Guiding Catheter

Configuration: Single Pack (1 pouch/box), Useable Catheter Length 100cm, Without side holes

5F 6F 7F 8F Shape

LEFT

GC-P5JL300N GC-P6JL300N GC-P7JL300N GC-P8JL300N JL3

GC-P5JL350N GC-P6JL350N GC-P7JL350N GC-P8JL350N JL3.5


GC-P5JL450N GC-P6JL450N GC-P7JL450N GC-P8JL450N JL4.5



GC-P5FL300N GC-P6FL300N GC-P7FL300N GC-P8FL300N FL3

GC-P5FL350N GC-P6FL350N GC-P7FL350N GC-P8FL350N FL3.5


GC-P5FL450N GC-P6FL450N GC-P7FL450N GC-P8FL450N FL4.5



GC-P5XL300N GC-P6XL300N GC-P7XL300N GC-P8XL300N XBLAD3

GC-P5XL350N GC-P6XL350N GC-P7XL350N GC-P8XL350N XBLAD3.5


GC-P5XL450N GC-P6XL450N GC-P7XL450N GC-P8XL450N XBLAD4.5


RIGHT

GC-P5JR300N GC-P6JR300N GC-P7JR300N GC-P8JR300N JR3

GC-P5JR350N GC-P6JR350N GC-P7JR350N GC-P8JR350N JR3.5


GC-P5JR450N GC-P6JR450N GC-P7JR450N GC-P8JR450N JR4.5



GC-P5FR300N GC-P6FR300N GC-P7FR300N GC-P8FR300N FR3

GC-P5FR350N GC-P6FR350N GC-P7FR350N GC-P8FR350N FR3.5


GC-P5FR450N GC-P6FR450N GC-P7FR450N GC-P8FR450N FR4.5



Multi Purpose

GC-P5MP000N GC-P6MP000N GC-P7MP000N GC-P8MP000N MPA

GC-P5HS000N GC-P6HS000N GC-P7HS000N GC-P8HS000N HS

AMPLATZ

GC-P5AL070N GC-P6AL070N GC-P7AL070N GC-P8AL070N AL.75

GC-P5AL100N GC-P6AL100N GC-P7AL100N GC-P8AL100N AL1

GC-P5AL150N GC-P6AL150N GC-P7AL150N GC-P8AL150N AL1.5



GC-P5AR100N GC-P6AR100N GC-P7AR100N GC-P8AR100N AR1

GC-P5AR200N GC-P6AR200N GC-P7AR200N GC-P8AR200N AR2







Extra Back Up

GC-P5XB300N GC-P6XB300N GC-P7XB300N GC-P8XB300N XB3

GC-P5XB320N GC-P6XB320N GC-P7XB320N GC-P8XB320N XB3.25



GC-P5XB400N GC-P6XB400N GC-P7XB400N GC-P8XB400N XB4



GC-P5EB300N GC-P6EB300N GC-P7EB300N GC-P8EB300N EBU3

GC-P5EB320N GC-P6EB320N GC-P7EB320N GC-P8EB320N EBU3.25








GC-P5XR300N GC-P6XR300N GC-P7XR300N GC-P8XR300N XBRCA3

GC-P5XR350N GC-P6XR350N GC-P7XR350N GC-P8XR350N XBRCA3.5


GC-P5XR400N GC-P6XR400N GC-P7XR400N GC-P8XR400N XBRCA4



GC-P5SR350N GC-P6SR350N GC-P7SR350N GC-P8SR350N SCR3.5

GC-P5SR400N GC-P6SR400N GC-P7SR400N GC-P8SR400N SCR4

GC-P5SR500N GC-P6SR500N GC-P7SR500N GC-P8SR500N SCR5

TRANSRADIAL

GC-P5RD000N GC-P6RD000N GC-P7RD000N N.A. RAD

GC-P5RM000N GC-P6RM000N GC-P7RM000N N.A. RBM

GC-P5RL350N GC-P6RL350N GC-P7RL350N N.A. RBL3.5

GC-P5RL400N GC-P6RL400N GC-P7RL400N N.A. RBL4

GC-P5RL450N GC-P6RL450N GC-P7RL450N N.A. RBL4.5

GC-P5RR300N GC-P6RR300N GC-P7RR300N N.A. RBR3

GC-P5RR350N GC-P6RR350N GC-P7RR350N N.A. RBR3.5

GC-P5RR400N GC-P6RR400N GC-P7RR400N N.A. RBR4

GC-P5TR300N GC-P6TR300N GC-P7TR300N N.A. TIG3

GC-P5TR350N GC-P6TR350N GC-P7TR350N N.A. TIG3.5


GC-P5TR450N GC-P6TR450N GC-P7TR450N N.A. TIG4.5


GC-P5RK000N GC-P6RK000N GC-P7RK000N N.A. RBK

By-Pass

GC-P5IM000N GC-P6IM000N GC-P7IM000N GC-P8IM000N IM

GC-P5BP010N GC-P6BP010N GC-P7BP010N GC-P8BP010N LCB

GC-P5BP020N GC-P6BP020N GC-P7BP020N GC-P8BP020N RCB







Catalogue numbers (II)


Configuration: Single Pack (1 pouch/box), Useable Catheter Length 100cm, Featuring 2 side holes

5F 6F 7F 8F Shape

LEFT

N.A. GC-P6JL300A GC-P7JL300A GC-P8JL300A JL3

N.A. GC-P6JL350A GC-P7JL350A GC-P8JL350A JL3.5


N.A. GC-P6JL450A GC-P7JL450A GC-P8JL450A JL4.5



N.A. GC-P6FL300A GC-P7FL300A GC-P8FL300A FL3

N.A. GC-P6FL350A GC-P7FL350A GC-P8FL350A FL3.5


N.A. GC-P6FL450A GC-P7FL450A GC-P8FL450A FL4.5



N.A. GC-P6XL300A GC-P7XL300A GC-P8XL300A XBLAD3

N.A. GC-P6XL350A GC-P7XL350A GC-P8XL350A XBLAD3.5


N.A. GC-P6XL450A GC-P7XL450A GC-P8XL450A XBLAD4.5


RIGHT

N.A. GC-P6JR300A GC-P7JR300A GC-P8JR300A JR3

N.A. GC-P6JR350A GC-P7JR350A GC-P8JR350A JR3.5


N.A. GC-P6JR450A GC-P7JR450A GC-P8JR450A JR4.5



N.A. GC-P6FR300A GC-P7FR300A GC-P8FR300A FR3

N.A. GC-P6FR350A GC-P7FR350A GC-P8FR350A FR3.5


N.A. GC-P6FR450A GC-P7FR450A GC-P8FR450A FR4.5



Multi Purpose

N.A. GC-P6MP000A GC-P7MP000A GC-P8MP000A MPA

N.A. GC-P6HS000A GC-P7HS000A GC-P8HS000A HS

AMPLATZ

N.A. GC-P6AL070A GC-P7AL070A GC-P8AL070A AL.75

N.A. GC-P6AL100A GC-P7AL100A GC-P8AL100A AL1

N.A. GC-P6AL150A GC-P7AL150A GC-P8AL150A AL1.5



N.A. GC-P6AR100A GC-P7AR100A GC-P8AR100A AR1

N.A. GC-P6AR200A GC-P7AR200A GC-P8AR200A AR2







Extra Back Up

N.A. GC-P6XB300A GC-P7XB300A GC-P8XB300A XB3

N.A. GC-P6XB320A GC-P7XB320A GC-P8XB320A XB3.25



N.A. GC-P6XB400A GC-P7XB400A GC-P8XB400A XB4



N.A. GC-P6EB300A GC-P7EB300A GC-P8EB300A EBU3

N.A. GC-P6EB320A GC-P7EB320A GC-P8EB320A EBU3.25








N.A. GC-P6XR300A GC-P7XR300A GC-P8XR300A XBRCA3

N.A. GC-P6XR350A GC-P7XR350A GC-P8XR350A XBRCA3.5


N.A. GC-P6XR400A GC-P7XR400A GC-P8XR400A XBRCA4



N.A. GC-P6SR350A GC-P7SR350A GC-P8SR350A SCR3.5

N.A. GC-P6SR400A GC-P7SR400A GC-P8SR400A SCR4

N.A. GC-P6SR500A GC-P7SR500A GC-P8SR500A SCR5

TRANSRADIAL

N.A. GC-P6RD000A GC-P7RD000A N.A. RAD

N.A. GC-P6RM000A GC-P7RM000A N.A. RBM

N.A. GC-P6RL350A GC-P7RL350A N.A. RBL3.5

N.A. GC-P6RL400A GC-P7RL400A N.A. RBL4

N.A. GC-P6RL450A GC-P7RL450A N.A. RBL4.5

N.A. GC-P6RR300A GC-P7RR300A N.A. RBR3

N.A. GC-P6RR350A GC-P7RR350A N.A. RBR3.5

N.A. GC-P6RR400A GC-P7RR400A N.A. RBR4

N.A. GC-P6TR300A GC-P7TR300A N.A. TIG3

N.A. GC-P6TR350A GC-P7TR350A N.A. TIG3.5


N.A. GC-P6TR450A GC-P7TR450A N.A. TIG4.5


N.A. GC-P6RK000A GC-P7RK000A N.A. RBK

By-Pass

N.A. GC-P6IM000A GC-P7IM000A GC-P8IM000A IM

N.A. GC-P6BP010A GC-P7BP010A GC-P8BP010A LCB

N.A. GC-P6BP020A GC-P7BP020A GC-P8BP020A RCB







Catalogue numbers (III)


Configuration: Five Pack (5 pouches/box), Useable Catheter Length 125cm, Catheter without side holes.

6F Shape

GC-P6MP102N MP1

GC-P6RN102N RN1

GC-P6RN202N RN2

GC-P6RN302N RN3

GC-P6JR402N JR4

GC-P6IM002N IM

Configuration: Five Pack (5 pouches/box), Useable Catheter Length 125cm, Featuring 2 side holes.

6F Shape

GC-P6MP102A MP1

GC-P6RN102A RN1

GC-P6RN202A RN2

GC-P6RN302A RN3

GC-P6JR402A JR4

GC-P6IM002A IM







Attachment 4

Device Nomenclature

Device Category (ISO 15225 & GMDN database):

Codes: Terms:

10 Single Use devices

Device Subcategory - Collective Term (GMDN database):

Code: Term:

CT 477 Cardiovascular Catheters

Generic Device Group (GMDN database):

Preferred Term: Intravascular Guiding Catheter

GMDN Code: GMDN: 17846

ECRI: 17846 [Emergency Care Research Institute Nomenclature]

GMDN Definition (type, appearance, material, purpose & mechanism of action): A flexible tube with a central lumen used for the percutaneous, transluminal passage and placement of guidewires and diagnostic/interventional devices within the vascular system. After the tube is inserted in position, a guidewire is advanced through its lumen and tracked over by a diagnostic/interventional device (e.g., balloon dilatation catheter, stent and delivery system, or embolization device) to the intended location. The distal section of the tube can have a variety of preformed shapes. This is a single-use device.

Device Type:


Customs HS-Code:

Harmonized Commodity Description & Coding System (HS) of tariff nomenclature per World Customs Organization

HS CODE: 901839: 9018 Medical Devices 901839 Catheters


Date: 2014-01-14

http://en.wikipedia.org/wiki/Tariff

http://en.wikipedia.org/wiki/Nomenclature







Attachment 5

Declarations of Conformity to applied International Standards PendraCare International B.V. hereby declares that

Climber™ Guiding Catheter meets the applicable requirements of the following International Standards*

Standard: Title:

(EN-) ISO 13485 Quality Systems – Medical Devices –System requirements for regulatory purposes.

EN-ISO/TR 14969

Quality systems – Medical Devices – Guidance on the application of ISO 13485 and ISO 13488.

(EN-) ISO 14971 Medical Devices – Application of Risk Management to Medical Devices

ISO 10555-1 Sterile Single-use intra-vascular catheters; General requirements.

ISO 594-1 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment. Part one: General requirements.

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood.

ISO 10993-5 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity

ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

ISO 10993-11 Biological evaluation of medical devices - Part 11: tests for systemic toxicity

ISO 14155 Clinical investigation of medical devices for human subjects - Good Clinical Practice

EN 1041 Information supplied by the manufacturer with medical devices

ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

ISO 11607-1 Packaging for terminally sterilized medical devices. Part-1 Requirements for materials, sterile barrier systems and packages systems.

ISO 17050-1 Conformity assessment - Supplier's declaration of conformity - Part 1: General requirements

ISO 17050-2 Conformity assessment - Supplier's declaration of conformity - Part 2: Supporting documentation

ISO 14644-1 Cleanrooms and associated controlled environments – part 1: classification of air cleanliness

ISO 14644-2 Cleanrooms and associated controlled environments – part 2: Specification for testing and monitoring to prove continued compliance with ISO-14644-1

ISO 14644-3 Cleanrooms and associated controlled environments – part 3: Metrology and test methods.

ISO 14644-4 Cleanrooms and associated controlled environments – part 4: Design, construction and start up

EN 556-1 Sterilization of medical devices – Requirements for medical devices to be labelled “STERILE” - Part 1: Requirements for terminally sterilized medical devices

ISO 11737-1 Sterilization of medical devices – Microbiological methods – Estimation of population of micro-organisms on products (Bio-burden).

ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

* The revision numbers of the applied standards are indicated in the “list of standards” within the Essential Requirements Checklist


Date: 2014-01-14







Attachment 6

To whom it may concern

PendraCare International B.V. hereby declares the following for the

Climber™ Guiding Catheter

Sterilisation: PendraCare’s catheters are sterilized using Ethylene oxide (EtO) sterilization process. The sterilization process is validated per ISO 11135-1 with Sterility Assurance Level (SAL) of 10-6 (SAL = 10E-6). The products are, therefore, considered “STERILE”.

EtO-residuals: PendraCare’s Catheters meet the criteria for Ethylene Oxide sterilization residuals as laid down in ISO 10993-7 whereby the device is considered a “Limited Exposure Device” for which the average daily doses of

EO and ECH to the patient does not exceed 4 mg and 9 mg, respectively.

Packaging: The catheter is mounted on a mounting card within a single barrier (heat-sealed) pouch and placed with an “Instructions for Use” in a carton-box. The packaging meets ISO 11607-1& ISO 11607-2 “Packaging for terminally sterilized medical devices”.

Shelf life: Product’s sterility, safety and performance are guaranteed for a period of 36 months (three years) after sterilization. The shelf life - expiration date is printed on the product labels near the “Use By Date” (hour glass) symbol. This symbol is accompanied by a date to indicate that the device should not be used after the end of the year (yyyy) and month (mm) shown adjacent to the symbol (ISO 15223-1).

“Use-By-Date”

Symbol

PendraCare’s Catheter is a Cardiovascular Catheter for single use, i.e., single-patient, single procedure and single purpose use. The catheters should not be reprocessed, re-sterilized, and re-used.

PendraCare’s Catheter is labelled non-pyrogenic. The product does not result in bacterial endotoxin-mediated (USP<85>, USP<161>) or material-mediated (ISO 10993-11, USP <151>) pyrogenic responses.

PendraCare’s Catheter does not incorporate, as an integral part, a medicinal product. PendraCare’s Catheter does not contain tissue of biological origin, i.e., does not contain tissue of animal origin

or (human) blood derivatives. PendraCare’s Catheter is latex-free and does not contain phthalates. This statement comprises the medical

device, its packaging as well as its manufacturing processes. No latex or phthalates (e.g., DEHP) are used within PendraCare’s production-lines.

PendraCare’s Catheter does not contain soft-ware. Biocompatibility of PendraCare’s Catheter is confirmed by successful test results from biocompatibility testing

conducted per “current” ISO 10993 standards, including: ISO 10993-1 Biological Evaluation of Medical Devices (USP <1031>); ISO 10993-4 Haemocompatibility; ISO 10993-5 Cytoxicity (USP <87>); ISO 10993-7 Ethylene Oxide residues; ISO 10993-10 Sensitization and Irritation (USP <1184>) & Intracutaneous reactivity (USP <88>); ISO 10993-11 Systemic toxicity (acute); USP <661> Packaging (plastic containers – leachables)

PendraCare’s Catheter’s packaging meets the requirements of the Packaging & Packaging Waste Directive 94/62/EC (as amended by 2004/12/EC) and Standard EN 13427.


Date: 2014-01-14

Documents

Declaration of Conformity-Addendum