Identity
- Trade Name
- Verifine FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- ISY-8102912-100 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011833780 FDA UDI
- 510(k) Number
- K223453 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Insulin syringe/needle, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Insulin syringe/needle, basic
Verifine by Promisemed Medical Devices Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, basic.
- EasyTouch — MHC Medical Products · Class II
- EasyTouch — MHC Medical Products · Class II
- BH Supplies — ANREL DISTRIBUTION LLC · Class II
- BD Ultra-Fine — BECTON DICKINSON AND COMPANY · Class II
- droplet insulin syringes — HTL STREFA S A · Class II
- Insulin Syringe — Dynarex Corp. · Class II
- LiteTouch — AMITY HOLDINGS, LLC · Class II
- Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct — ARISE MEDICAL LLC · Class II
Cleared under the same submission
K223453 also covers:
- Easy Comfort Pro Insulin Syringes 30g 0.5in 1cc 40 count — HOME AIDE DIAGNOSTICS, INC.
- Easy Comfort Pro Insulin Syringes 30g 5/16” 1cc 40 count — HOME AIDE DIAGNOSTICS, INC.
- Easy Comfort Pro Insulin Syringes 31g 5/16” 1cc 40 count — HOME AIDE DIAGNOSTICS, INC.
- Easy Comfort Syringes 31G 1/2" 0.3CC — HOME AIDE DIAGNOSTICS, INC.
- Easy Comfort Syringes 31G 5/16" 0.3CC — HOME AIDE DIAGNOSTICS, INC.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
- Verifine — Promisemed Medical Devices Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Promisemed Medical Devices Inc.
Sources (1)
- FDA UDI e7c29199-278b-4287-b91a-06af39ce5c00 34 fields · synced May 30, 2026