FDA UDI
In Commercial Distribution
🇺🇸 United States
ook snow ALL
DI: 00670482000142
·
Model: 200-0000
·
Umano Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ook snow ALL
- Primary DI
- 00670482000142
- Version / Model
- 200-0000
- Catalog Number
- 200-0000
- Company Name
- Umano Medical Inc
- Labeler DUNS
- 249675476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-21
- Public Version
- 1
- Public Version Date
- 2018-09-21
- Public Version Status
- New
- Public Device Record Key
- 86c7ed56-07ff-4cd8-8e4f-c3c4cea66721
Device Description
AC-powered medical bed with 4 built-in electric DC actuators that offers a powered adjustment of the height and surface contours. Bed includes movable and latchable siderails, and control boards. The patient sleep surface can be manually extended of 4” with the integrated bed length extender and reach 84” or 88” long. The surface width can be manually extended from 35” up to 47”. The product offers a range of options and accessories including but not limited to integrated scale, integrated bed exit system, fixed or foldable IV pole, patient helper, oxygen bottle holder and length extension cushions.
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 |
|---|---|---|---|---|---|---|
| Primary | 00670482000142 | GS1 | ||||
| Package | 10670482000149 | GS1 | 1 | In Commercial Distribution |