← Back to catalogue
PRO1TEK Trauma First Aid Bleeding Control Kit-2+ Patient IFAK w/ BC
FDA UDIClass I (US FDA UDI)
by Pro1tek
Identity
- Trade Name
- PRO1TEK Trauma First Aid Bleeding Control Kit-2+ Patient IFAK w/ BC FDA UDI
- Generic Name
- First aid kit, non-medicated, single-use FDA UDI
- Device Name
- PRO1TEK Medical Trauma First Aid Bleeding Control Kit- 2+ Patient IFAK with Burn Cream FDA UDI
- Model / Reference
- B283E2IFBOD0 FDA UDI
- Description
- PRO1TEK Medical Trauma First Aid Bleeding Control Kit- 2+ Patient IFAK with Burn Cream FDA UDI
Identifiers
- Primary DI / UDI-DI
- B283E2IFBOD0 FDA UDI
- FDA Product Code
- OHO FDA UDI
- GMDN Term
- First aid kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4014 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: First aid kit, non-medicated, single-use
PRO1TEK Trauma First Aid Bleeding Control Kit-2+ Patient IFAK w/ BC by Pro1tek — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as First aid kit, non-medicated, single-use.
- IFAK — FARETEC, INC. · Class I
- NAR Kit — NORTH AMERICAN RESCUE, LLC.
- NAR Kit — NORTH AMERICAN RESCUE, LLC.
- NAR Kit — NORTH AMERICAN RESCUE, LLC.
- NAR Kit — NORTH AMERICAN RESCUE, LLC.
- Forward Tac-FAK Massive Hemorrhage (Tac-FAK M) — INTEGRATED MEDCRAFT LLC · Class I
- NAR — NORTH AMERICAN RESCUE, LLC.
- NAR Kit — NORTH AMERICAN RESCUE, LLC.
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pro1tek
Sources (1)
- FDA UDI 6f3eab1d-44cf-4706-8694-62c3f63f080d 34 fields · synced May 31, 2026