RevMed

Promisemed Medical Devices Inc. ISY-7053008-100 Verifine

Company Name
Promisemed Medical Devices Inc.
Catalog Number
ISY-7053008-100

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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Pricing
Summary

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Additional Details

Device Identifier
00850011833568
Is RX
No
Is Over the Counter
No
Requires Sterilization
No
Is Sterile
Yes
Is Single Use
Yes

Barcode Mapping

Unit of MeasurementEachesGTIN
Each180850011833564
Package of 10010000850011833568
Package of 2,000200010850011833565