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Promisemed Medical Devices Inc. ISY-8103108-100 Verifine

Company Name
Promisemed Medical Devices Inc.
Catalog Number
ISY-8103108-100

Description

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
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The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip /lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas and is labeled Non-Pyrogenic. The device is intended for single use only. Sku CS-3000
$0.08
General Hospital

Additional Details

Device Identifier
00850011833797
Is RX
No
Is Over the Counter
No
Requires Sterilization
No
Is Sterile
Yes
Is Single Use
Yes

Categories

Barcode Mapping

Unit of MeasurementEachesGTIN
Each180850011833793
Package of 10010000850011833797
Package of 2,000200010850011833794