Identity
- Trade Name
- AimScreen Fentanyl FDA UDI
- Generic Name
- Fentanyl IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- 42338 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684423384 FDA UDI
- FDA Product Code
- NGL FDA UDIDJG FDA UDI
- GMDN Term
- Fentanyl IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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: Fentanyl IVD, kit, rapid ICT, clinical
AimScreen Fentanyl by Germaine Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Fentanyl IVD, kit, rapid ICT, clinical.
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- Rapid Response — BTNX 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 |
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Manufacturer
- Manufacturer
- Germaine Laboratories, Inc.
Sources (1)
- FDA UDI d7a738ff-9b6d-4e6f-885c-feceeef39b46 32 fields · synced Jun 6, 2026