Identity
- Trade Name
- GBUK Ltd FDA UDI
- Generic Name
- Patient lifting system stretcher FDA UDI
- Device Name
- Air Assisted Flat Lifting Device, Reusable, 39” Wide w/bag FDA UDI
- Model / Reference
- B-FLOJAC39 EUDAMEDFDA UDI
- Description
- Air Assisted Flat Lifting Device, Reusable, 39” Wide w/bag FDA UDI
Identifiers
- Catalog Number
- B-FLOJAC39 FDA UDI
- Primary DI / UDI-DI
- 05060405748520 EUDAMEDFDA UDI
- Basic UDI-DI
- 506040574FloJacNX EUDAMED
- Direct Marketing DI
- 05060405748520 EUDAMED
- FDA Product Code
- FNG FDA UDI
- EMDN Code
- V08050399 PATIENT TRANSFER LIFTS - OTHER EUDAMED
- GMDN Term
- Patient lifting system stretcher FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5500 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
B-Flojac39 by GBUK Group — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506040574FloJacNX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GBUK Group
- EUDAMED SRN
- GB-MF-000002238
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED 88b9c427-6404-45c8-87f3-12664e5fed91 61 fields · synced Jun 19, 2026
- FDA UDI 797678c7-3ab4-43fa-b0a4-8c6e213cc163 34 fields · synced May 30, 2026