Identity
- Trade Name
- Insulin Syringe FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Model / Reference
- 6942 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784694221 FDA UDI
- 510(k) Number
- K112057 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
Yes
FDA UDI
Category: Insulin syringe/needle, basic
Insulin Syringe by Dynarex Corp. — 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
- LiteTouch — AMITY HOLDINGS, LLC · Class II
- Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct — ARISE MEDICAL LLC · Class II
- Monoject — Cardinalhealth · Class II
Cleared under the same submission
K112057 also covers:
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 05acf0c8-e047-4e39-8164-246e35f720d0 33 fields · synced May 31, 2026