MAIS INDIA - cdn.kitsune.tools · I.V. Cannula / Medical Disposables industry in India back in early 1990s. “Harbel Singh is the Managing Director of Mais India Medical Devices

“Leading the global revolution in medical disposables”

M IAIS NDIAMEDICAL DEVICES

A SYSMECH-MAIS JOINT VENTURE

M Iais ndia

“We seek to ensure that the benefits ofbest modern technology in healthcare isavailable to all at an affordable price”

“To become a corporation known for itsinstrumental role in welfare of mankindby producing high quality medicalproducts at lower prices using cuttingedge technology and incessant research”

STRATEGIC DIRECTION

VISION MISSION

Saudi Mais Medical Sysmech Enterprises

Mais India Medical Devices

CORPORATE STRUCTURE Offering truly integrated and

comprehensive medical

disposable solutions”

List of Core Products • IV Cannula Assembly Machines

ON Type Cannula Assembly M/c•

Autometic / Semi-automatic IV Cannula / •

3 Way Stop Cock / AV Fistula Production Line

Moulds (IV Cannula, 3 Way Stop Cock, IV Set etc)•

• Great reputation in Middle East Market in medical disposables

• Makes and sells more than 100 single time usable medical products

• India’s only premium medical disposable machines manufacturer

ISSUES HAUNTING PREMIUM MEDICAL DISTRIBUTORS

&COMPANIES IN OUTSOURCING

IV CANNULA

• Quality Issues

Meeting of Demand/ Capacity•

Effective Decision Making•

Resource Optimization•

Statutory Compliance•

Integration with External Systems•

THE ULTIMATE SOLUTION

M IAIS NDIAMEDICAL DEVICES

OUR FOUNDATION ROOTS

Our Enormously Experienced Management We guarantee HIGHEST QUALITY IV Cannula across the globe

Ensure Maximum EFFICIENCY

Top Delivery (Always ready before time)

Modest Pricing

WHAT MAKES US SPECIAL?

We actually mean that when we say MAIS INDIA manufactures the HIGHEST QUALITY I.V. Cannula across the globe

Our cannula has the LOWEST PENETRATION LOAD in the industry, even lower than any premium manufacturer across the globe

We have AUTOMATIC COMPUTERIZED VISION INSPECTION SYSTEM set up for entire cannula manufacturing facility.

ConsistentTop Quality

MinimalBio-burden

Zero ManualError


Brief Work Summary of our Managing Director

Our team is composed of those people who actually establishedI.V. Cannula / Medical Disposables industry in India back in early 1990s.

“Harbel Singh is the Managing Director of Mais India Medical Devices Pvt Ltd.

A mechanical engineer by qualification with decades of technical experience at his back, he is the mostknowledgeable and famous professional in the entire Indian medical disposable industry. His in-depth knowledge,exceptional managerial skills and tremendous business acumen has helped various renowned medical business unitsto reach the pinnacle of success.

In his career span of more than 30 years, he played an instrumental role in the top management of firms such as Hindustan Syringes, Poly Medicure Ltd, Eastern Medikit and others.

Finally, he retired as Senior General Manager from Poly Medicure Ltd in 2008. He also heads Sysmech Enterprises, theonly company in India to manufacture totally automatic IV Cannula Production Lines, AV Fistula Assembly Machines,3 Way Stop Cock Assembly Machines and other key products.

Currently, he is also involved in helping various international firms such as Nipro Corporation, Japan in setting up theiroperations through his exceptional experience and expertise.”


ULTRA MODERN INFRASTRUCTURE

Assembly Area/ Manufacturing Area –

Clean Room Class 10,000 or ISO Class 7



Moulding Area

–

Clean Room

Class 100,000 Or ISO Class 8

The entire moulding area is planned to meet Class 100,000 purity standard of US FED 209E (i.e. not morethan 100,000 particles of size 0.5 microns per cubic feet of air)

equivalent to ISO Class 8 at dynamic state using HEPA filters



Lab (Class 10,000 and Class 1,000) _

ISO Class 6 and ISO Class 7



The top management appoints Regulatory Affairs and Quality leadership

teams to administer company-wide compliance with global regulations,

including design controls, marketing authorisations, quality systems,

applicable standards, and labelling.

All the sub-processes from the procurement of raw material to dispatch of

finished good are efficiently managed by defining procedures, controlling

documentation and maintaining of records. This ensure product, process

and system changes at all levels are based on priorities from quality

metrics, eliminating root causes and verifying results.

Regular audit of the quality system provides valuable inputs for taking the necessary corrective and pre-cautionary action.

We determine customer requirements, implement systems to meet or exceed those requirements, and maintain effective relationships with our customers, who are our primary focus. We are passionate for our customer’s satisfaction and continuously involve customers in giving feedback for the product performance as well as in the evaluating theresult in our improvements.

We support associate participation, teamwork, open communication,

and incessant improvement to achieve the company’s objectives.

Controlled Processes

Audits

Teamwork

Customer Satisfaction

SteeringCommittee

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MAIS INDIA INFUSION SYSTEMS

• Infusion therapy includes all actions related with the administration of fluids, nutrients or medications, as well as injectable drugs

• It may also refer to situations where drugs are provided through othernon - oralroutes , suchasintr a muscular injections and epidural routes (into the membranes surrounding the spinal cord)

• Infusion therapy involves the administration of medication through a needle or catheter. It is prescribed when a patient’s condition cannot be treated effectively by oral medications


MAIS INDIA PRODUCT RANGE


I.V. Cannula

I.V. CannulaWith Flashback technology

MaisonBasic

MaisonStandard

MaisonPlus

MaisonPremium

MaisonInstant Flashback



Infusion Set

Infusion SetWith Airvent

Infusion SetWith Microdrip

Infusion SetWithout Airvent

Maisfusion SetWith Airvent

Maisfusion SetWith Microdrip

Maisfusion SetWithout Airvent



3 Way Stop Cock

3 Way Stop CockWith Extension Tube

MaiswayWith Extension Tube

MaiswayLipid Resistant

MaiswayNormal

3 Way Stop CockNormal

3 Way Stop CockLipid Resistant



Measured VolumeFluid Administration Set

MaisvolBurette Set - 110 ml

MaisvolBurette Set - 150 ml



Extension Line

High PressureExtension Line

Low PressureExtension Line


MAIS INDIA

I.V. Cannula

Sterile tubular device incorporated with an injection port which is initiatedinto a peripheral vein for directing drugs by intravenous route, creating aninfusion or a blood transfusion

Sizes Offered – 14G to 26G

(Large Bore Cannula – Rapid Fluid Administration)


MAIS INDIA

I.V. CannulaDifferent Size

14G Trauma patients / Major volume replacement

16G Trauma patient / Major surgery / Intra or post-partum GIT bleeding

18G Blood products & Delivery of irritant medications

20G • IV maintenance

• IV antibiotics

• IV anaelgesia

22G Paediatrics / Fragile veins

24G Paediatrics / neonates

26G

A SYSMECH-MAIS JOINT VENTURE MAIS INDIA PRODUCT

MAISFLON Standard• I.V. Cannula with port & wings• Sizes : 14G to 26G

A SYSMECH-MAIS JOINT VENTUREMAIS INDIA PRODUCT

MAISFLON Plus• I.V. Cannula with port & wings• Snap Fit Cap• Sizes : 14G to 26G


MAISFLON Premium• I.V. Cannula with port & wings• Flip Top Cap• Coloured Body• Sizes: 14G to 26G• Also available with Quick Flashback

A SYSMECH-MAIS JOINT VENTUREMAISFLON

The needle is AISI 304 stainless steel and siliconized. It is equipped with extremely sharp triple facet bevel for smooth and effortless venipuncture.

Common Features for all variants

Painless and smooth venipuncture is confirmed with smooth internal and external surfaces of the catheter. It is kink resistant and made up of biocompatible material PTFE/FEP/PU. Catheters used are radiopaque so that they are visible using fluoroscopy. During fluoroscopy, the stripes absorb x-rays, making the catheter visible. The tip of the catheter is mildly tapered and aligned with bevel to ensure easy transition from needle to catheter.

It has been technically engineered to perfection in order to prevent any instability during insertion of needle. Firm grip on hub provides extremely good support during insertion.

Needle

Catheter

Needle Hub

Completely transparent flashback chamber gives an instant verification of venipuncture.

Flashback chamber

A SYSMECH-MAIS JOINT VENTURE MAISFLONCommon Features for all variants

The wings are flexible in order to deliver easy-going and protected fixation. It also prevents dislocation of cannula over the patient’s body.

Wings

Each product is individually packed in blister and sterilized using Ethylene Oxide. The pealing of the seal is smooth and easy.

Packaging

It has a specifically designed double-hinged cap that incorporates a recessed plug with a protectiveskirt designed and engineered to prevent contamination when the valve is not being used.

Injection Port Cap

Thread Stopper / Luer LockSpecially designed in compliance with international standards to ensure no bleeding during the offline mode.

A SYSMECH-MAIS JOINT VENTUREMAISFLON

INSTANT FLASHBACK

STEP 1Standard Flashback is established as the needle (not the Catheter) is progressed into the vein

STEP 2Flashback corroborates accurate progression andis noticeable amid the catheter and the needle

STEP 3The Instant flashback feature verifies appropriatecatheter location with rapid flash evident along the whole stretch of the catheter

A SYSMECH-MAIS JOINT VENTURE FLASH BACK

WHY INSTANT FLASH BACK???

Pleasant doctor and patient experience

Instant first prick success

Challenging venipuncture made easy

Negligible risk of injury


MAISWAY

• Pressure Handling Capability : 4.5 bar• Tap available: Red, White, Blue


MAISWAY

Lipid Resistant

• Pressure Handling Capability : 4.5 bar


MAISWAY With Extension Tube

• Three Way Stop Cock at one end & male luer lock at the other end of extension tube• High quality kink resistant tube that provides smooth flow• Tube length available (cm): 10, 25, 50, 80, 100, 150, 200

A SYSMECH-MAIS JOINT VENTURE MAISWAYCommon Features for all variants

• Transparent channel made of bio compatible polycarbonate for easy visualization of fluids

• Pressure Handling Capability : 4.5 bar

• Universal 6% taper to make it compatible with wide range of other medical equipment

• Sterile, single use and non-pyrogenic Rotation allowed - 360°

• Arrow symbols to indicate the direction of flow

• Minimum priming volume required for correct drug administration


INFUSION SETMaisfusion Set


MAISFUSION SET

With Airvent

• Sharp and easy piercing airvented spike with bacteria barrier incorporating snap cap• Smooth roller clamp for controlling flow rate• Latex free bulb at distal end for sporadic medication• Approximately 20 drops/ml


MAISFUSION SETWithout Airvent

• I.V. infusion set without airvented spike• Approximately 20 drops/ml


MAISFUSION SET

With Microdrip

• I.V. Infusion Set for paediatric use• Sharp spike for easy and quick penetration• Approximately 60 drops/ml

A SYSMECH-MAIS JOINT VENTUREMAISFUSION SETCommon Features for all variants

• Single use, sterile and non-pyrogenic; Gravity Feed

• Transparent and flexible drip chamber for easy fluid adjustment and drop count

• 15-micron fluid filter in drip chamber

• Soft and kink resistant PVC tubing ensures accurate uniform flow rate without restriction

• Strong self sealing latex free bulb

• Fine roller clamp enables easy, safe control and adjustment of fluid rates

• Tube length: 150 cm;Tube dia - Int. » 3.0mm & Ext. » 4.1mm

A SYSMECH-MAIS JOINT VENTURE MAISFUSION

Customize your Infusion Set with Different Accessories

Luer Lock Rotating Luer Lock Needle Free Y-Site Luer Slip


EXTENSION LINE


HIGH PRESSUREEXTENSION LINE

• Suitable for high pressure monitoring• Kink resistant PVC tubing• 6% male and female luer locks• Single use, sterile and non-pyrogenic• Pressure handling capacity : 800 psi• Tube dia: Int (1.5mm) Ext (3.0mm) • Different sizes (cm) :25,50,100,150,200


LOW PRESSUREEXTENSION LINE

• Suitable for low pressure applications• Kink resistant PVC tubing• Single use, sterile and non-pyrogenic• Pressure handling capacity : 5 bars• 6% luer compatibility with any other product• Tube dia: Int (3.0mm) Ext (4.1mm) • Different sizes (cm): 25,50,100,150,200

A SYSMECH-MAIS JOINT VENTURE MAIS INDIA EXTENSION LINS

Y Injection

Customize your Extension Line with Different Accessories

Y Injection Port (Also available with Latex – Free)


MAISVOLBURETTE SET

Measured Volume Fluid Administration Set

A SYSMECH-MAIS JOINT VENTURE MAISVOL Features

• Transparent cylindrical and calibrated drip chamber for easy fluid level adjustment and drop count

• Air inlet with bacteria barrier

• Injection port for extra medication

• Automatic shut off valve to prevent air embolism as well as indicate level of fluid

• 15 µm disc type fluid filter; Drops per ml : 60

• Kink resistant PVC tubing; Length of set (cm) : 150

• Tube dia - Int. » 3.0mm & Ext. 4.1mm

• Available in two sizes (ml) : 110 & 150

A SYSMECH-MAIS JOINT VENTUREMAISVOL BURETTE SET

Customize your Measured Volume Set with Different Accessories

Luer Lock Rotating Luer Lock Needle Free Y-Site Luer Slip

Y Injection Non Vented Spike Air Vented Spike

A SYSMECH-MAIS JOINT VENTURE FAQs - PRODUCTION

• How is I.V. Cannula sterilization done? IV Cannula is sterilized by EO (Ethylene Oxide) Gas

• How long will be the shelf life of I.V. Cannula? The shelf life of I.V. Cannula is 5 years from the manufacturing date

• Why is the catheter radiopaque? Catheters are radiopaque so that they are visible using fluoroscopy. The biocompatible fluoroscopy stripes on the catheters act like markers. During fluoroscopy, the stripes absorb x-rays, making the catheter visible.

A SYSMECH-MAIS JOINT VENTUREFAQs - PRODUCTION

• Which material is used in Catheter? Virgin P.T.F.E (Poly Tetra Fluro Ethylene) double tapered beveled tip siliconised catheter. Also FEP & PU

• What are the Gauges of I.V. Cannula do you manufacture? Our I.V. Cannula with PTFE catheter range is as follows - 14G, 16G, 17G, 18G, 20G, 22G, 24G and 26G

• What is the benefit of Tyvek paper? The constituent of Tyvek paper is high-density polyethylene fiber. It has all the advantages of paper, fabric and plastic. This, it does not get worn out easily.

• Which international standards does Mais India follow? Mais India strictly follows the guidelines and recommendations of ISO 9001, ISO13485, and MDD 93/42/EEC as amended till date

A SYSMECH-MAIS JOINT VENTURE MAIS INDIA ADVANTAGES


M Iais ndia

Trained Experienced Technology &

Business Professionals

Transparent &

ser Friendly

Client - Centric

In-depth Industry

Knowledge

State-of-the-art Infrastructure

Top Service Delivery

Hands-on Experience

Tested Methodologies

and Work Model

A SYSMECH-MAIS JOINT VENTUREIS THIS HAPPENING TO YOU?

• POOR QUALITY I.V. CANNULA

• UNREASONABLE PRICES

• INADEQUATE CAPACITY OF SUPPLIER

• LATE DELIVERY OF SHIPMENTS

• STUCK WITH BAD SUPPLIER

• ZERO ENGINEERING CAPABILITY OF SUPPLIER

A SYSMECH-MAIS JOINT VENTURE MAIS INDIA

MAIS INDIA with its enormously experienced leadership team (The originators of I.V. Cannula machines in India back in early 1990’s)

And

State-of-the-art facility (Fully Automatic Production Assemble Lines, Completely Equipped

R&D Facility, In-house advanced Engineering Capability and Automatic Vision Inspection

System for Entire Facility)

Gives

You a Guarantee of the HIGHEST QUALITY I.V. CANNULA and other medical disposables

across the globe

A SYSMECH-MAIS JOINT VENTUREDON’T WAIT

GIVE US A CALL

GET TOP DELIVERY

AND SEERESULT

A SYSMECH-MAIS JOINT VENTURE MAIS INDIA

WITH MAIS INDIAFRUITFUL ASSOCIATION IS GUARANTEED


Mais India

A SYSMECH-MAIS JOINT VENTUREMAIS INDIA

“It is not the strongest of thespecies thatsurvives, not themost intelligent,but the one mostresponsive tochange.”

Charles Darwin, 1809


M Iais ndia

MAIS INDIA MEDICAL DEVICES525 P, Sector- 37, Pace City-II,

Gurgaon-122001, Haryana, INDIA

Tel: +91 8527595999

[email protected], [email protected]

www.maisindia.com

Documents

MAIS INDIA - cdn.kitsune.tools · I.V. Cannula / Medical Disposables industry in India back in early 1990s. “Harbel Singh is the Managing Director of Mais India Medical Devices