FDA UDI
In Commercial Distribution
🇺🇸 United States
REMOVABLE PATIENT CONTROL – 2 FUNCTIONS
DI: 00670482000845
·
Model: FA64511-TRI
·
Umano Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- REMOVABLE PATIENT CONTROL – 2 FUNCTIONS
- Primary DI
- 00670482000845
- Version / Model
- FA64511-TRI
- Catalog Number
- FA64511-TRI
- Company Name
- Umano Medical Inc
- Labeler DUNS
- 249675476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-17
- Public Version
- 1
- Public Version Date
- 2024-09-25
- Public Version Status
- New
- Public Device Record Key
- aa01970b-f5e0-4cca-b7e0-60575cf6f5bf
Device Description
A hand-operated electronic device that has a functional connection to an electrically powered medical bed to control its operation.
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
- 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 |
|---|---|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | General Hospital | 880.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37991 | Bed remote control | A hand-operated electronic device that has a functional connection to an electrically-powered medical bed to control its functions, typically the articulations and/or the raising/lowering of the bed. It may be connected to the bed via an electrical cable or operate cordless (wireless). It is typically operated by the occupant but may be utilized by the nursing/attending staff. Some types may integrate other functions for patient use (e.g., communication with the staff, radio/television operation). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10670482000842 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00670482000845 | GS1 |