CHECK THE DATE THATS HIGH LITED Profile: Univec, I

CHECK THE DATE THATS HIGH LITED Profile: Univec, Inc. specializes in offering antistick syringes, enteral irrigation kits and piston syringes.

3 Products/Services (Click for related suppliers)
• Antistick Syringe (FDA Code: MEG / 880.5860)
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
• Enteral Irrigation Kit w/Piston Syringe
• Piston Syringe (FDA Code: FMF / 880.5860)


Product Classification
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Device Syringe, Antistick
Regulation Description Piston syringe.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product Code MEG
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting Eligible
Recognized Consensus Standards
5-133 ISO 80369-7 Second edition 2021
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
6-11 ISO 594-1 First edition 1986-06-15
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
6-129 ISO 594-2 Second edition 1998-09-01
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
6-148 ISO 7886-3 First edition 2005-03-01
Sterile hypodermic syringes for single use -- Part 3: Auto-disable syringes for fixed-dose immunization
6-174 ISO 11608-4 First edtion 2006-03-15
Pen-injectors for medical use -- Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
6-273 ISO 23908 First edition 2011-06-11
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
6-275 ISO 11608-2 Second edition 2012-04-01
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
6-278 ISO 11040-5 Third edition 2012-02-15
Prefilled syringes - Part 5: Plunger stoppers for injectables
6-294 ISO 11608-3 Second edition 2012-10-01
Needle based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
6-341 ISO 11608-1 Third edition 2014-12-15
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
6-365 ISO 11040-4 Third edition 2015-04-01
Prefilled syringes - Part 4: Glass barrels for injectables
6-377 ISO 11608-5 First edition 2012-10-01
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated function.
6-382 ISO 11608-7 First edition 2016-08-01
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
6-441 ISO 7886-3 Second edition 2020-05
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Eligible for Accredited Persons Program
Accredited Persons
Accelerated Device Approval Services
Center For Measurement Standards Of Industrial
Global Quality And Regulatory Services
Regulatory Technology Services, Llc
Sgs North America
Third Party Review Group, Llc
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Page Last Updated: 01/25/2021

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