FDA UDI
In Commercial Distribution
🇺🇸 United States
Handi-Move Rail System
DI: 05404016612977
·
Model: 3961 00000001
·
Handi-Move
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Handi-Move Rail System
- Primary DI
- 05404016612977
- Version / Model
- 3961 00000001
- Company Name
- Handi-Move
- Labeler DUNS
- 283658730
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-18
- Public Version
- 1
- Public Version Date
- 2021-08-26
- Public Version Status
- New
- Public Device Record Key
- dad7bac7-539e-4640-9df1-7c2a10868819
Device Description
Turntable 3961
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FSA | Lift, patient, non-ac-powered | General Hospital | 880.5510 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38129 | Overhead track patient lifting/transfer system | A electrically-powered assembly of devices designed to enable an incapacitated patient or a person with a disability to be lifted/moved (transferred) safely and with minimal physical effort within the confines of one floor of a building, typically an institution or the person's home. It typically consists of ceiling-mounted track, and a motorized hoist and patient holding device (e.g., a sling, holder or a frame) for lifting and lowering the patient, that can be moved along the overhead track. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05404016612977 | GS1 |