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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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 Measurement | Eaches | GTIN |
|---|---|---|
| Each | 1 | 80850011833564 |
| Package of 100 | 100 | 00850011833568 |
| Package of 2,000 | 2000 | 10850011833565 |