FDA UDI
In Commercial Distribution
🇺🇸 United States
Accora FloorBed 6 Bed Lever Assist Bar
DI: 05056147700148
·
Model: Bed Lever Assist Bar
·
ACCORA LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Accora FloorBed 6 Bed Lever Assist Bar
- Primary DI
- 05056147700148
- Version / Model
- Bed Lever Assist Bar
- Catalog Number
- STLEV-0-FL6-000
- Company Name
- ACCORA LIMITED
- Labeler DUNS
- 736558755
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-01
- Public Version
- 2
- Public Version Date
- 2021-07-21
- Public Version Status
- Update
- Public Device Record Key
- ce64cd2e-8396-4f1e-83bd-f9f705c612b9
Device Description
FloorBed / Empresa Standard Bed Lever Assist Bar, FB6
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| IKX | Aid, Transfer | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61456 | Patient repositioning lever-board | A portable, manual device intended to be used by a healthcare provider(s) to assist the repositioning of a patient from supine to a seated position. It is a board/frame with handles that is shaped with a turn which functions as a pivot point to lever the patient from horizontal position (i.e., foetal-type position with legs supported over the bed edge) to a vertical position (i.e., seated); it may also be used to reposition the patient to a supine position. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056147700148 | GS1 |