FDA UDI
In Commercial Distribution
🇺🇸 United States
Body Armor® PFA Walker Liner
DI: 04251853902874
·
Model: BAPFAL4
·
Darco (Europe) GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Body Armor® PFA Walker Liner
- Primary DI
- 04251853902874
- Version / Model
- BAPFAL4
- Catalog Number
- BAPFAL4
- Company Name
- Darco (Europe) GmbH
- Labeler DUNS
- 343551081
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-15
- Public Version
- 2
- Public Version Date
- 2025-09-24
- Public Version Status
- Update
- Public Device Record Key
- 5d877b41-145f-4893-b8c2-a9454a3a3c05
Device Description
Liner, Gray, XL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZF | Splint, Extremity, Inflatable, External | General, Plastic Surgery | 878.3900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32302 | Inflatable extremity splint, reusable | A sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb following injury. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies to stabilize the limb for transport to a hospital. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04251853902874 | GS1 |