Identity
- Trade Name
- DARCO® Body Armor® ProTerm FDA UDI
- Generic Name
- Inflatable extremity splint, reusable FDA UDI
- Device Name
- Medium Black FDA UDI
- Model / Reference
- BAPT2 FDA UDI
- Description
- Medium Black FDA UDI
Identifiers
- Catalog Number
- BAPT2 FDA UDI
- Primary DI / UDI-DI
- 00609271039254 FDA UDI
- FDA Product Code
- FZF FDA UDI
- GMDN Term
- Inflatable extremity splint, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.3900 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Inflatable extremity splint, reusable
DARCO® Body Armor® ProTerm by Darco (Europe) GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inflatable extremity splint, reusable.
- SC — Allied Medical LLC · Class I
- DARCO® Body Armor® Night Splint — DARCO International, Inc. · Class I
- DARCO® AirTraveler™ Walker Liner — DARCO International, Inc. · Class I
- First Aid Only — ACME UNITED CORP. · Class I
- DARCO® AirTraveler™ Walker Liner — DARCO International, Inc. · Class I
- DARCO® AirTraveler™ Walker Liner — DARCO International, Inc. · Class I
- DARCO® Night Splint — DARCO International, Inc. · Class I
- SC — Allied Medical LLC · Class I
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
- Darco (Europe) GmbH
Sources (1)
- FDA UDI fa679f51-878f-4520-8636-b26a09147e27 34 fields · synced May 29, 2026