FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Freedom 500
DI: 00670482000128
·
Model: FM500
·
Umano Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Freedom 500
- Primary DI
- 00670482000128
- Version / Model
- FM500
- Catalog Number
- FM500
- Company Name
- Umano Medical Inc
- Labeler DUNS
- 249675476
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-10
- Public Version
- 4
- Public Version Date
- 2021-02-08
- Public Version Status
- Update
- Public Device Record Key
- 757e11d0-9b6b-4b35-93fd-af2680495d4d
- Distribution End Date
- 2021-02-03
Device Description
Medical bed.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 34870 | Basic electric hospital bed | A mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 00670482000081 | GS1 | ||||
| Primary | 00670482000128 | GS1 | ||||
| Package | 10670482000125 | GS1 | 1 | Not in Commercial Distribution | 2021-02-03 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 158 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity