Identity
- Trade Name
- AQUILAVIE FDA UDI
- Generic Name
- Insulin syringe/needle, safety FDA UDI
- Device Name
- Disposable Insulin Syringe, U-100, 1mL 31G 5/16"/1CC (0.25mm x 8mm),10pcs/bag, 10bags/box, 5boxes/case, 6cases/carton FDA UDI
- Model / Reference
- J10355 FDA UDI
- Description
- Disposable Insulin Syringe, U-100, 1mL 31G 5/16"/1CC (0.25mm x 8mm),10pcs/bag, 10bags/box, 5boxes/case, 6cases/carton FDA UDI
Identifiers
- Catalog Number
- J10355 FDA UDI
- Primary DI / UDI-DI
- 10810118890397 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Insulin syringe/needle, safety 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
Yes
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, safety
Aquilavie by Ahc Americas LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, safety.
- SecureSafe Syringe With Safety Needle — Dynarex Corp. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
- ONE-CARE Safety Pen Needles 30G x 8mm, Yellow, — MediVena, LLC · Class II
- Endure — ENDURE INDUSTRIES, INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Disposable Insulin Syringe — Berpu Medical Technology Co., Ltd · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
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
- Ahc Americas LLC
Sources (1)
- FDA UDI 7702c55f-951f-49bd-99bf-44190c7f35b6 34 fields · synced Jun 8, 2026