ook snow
Basic Information
- Brand Name
- ook snow
- Primary DI
- 00670482000104
- Version / Model
- FL36 ook snow
- Catalog Number
- FL36
- Company Name
- Umano Medical Inc
- Labeler DUNS
- 249675476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-10
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6fb2d236-9a1a-4098-90cd-d6775d35eddc
Device Description
The ook snow is an AC-powered medical bed with 4 built-in electric DC actuators. The height and surface contours are adjustable. The bed includes movable and latchable siderails, and control boards. The product offers a range of options and accessories outlined in the manuals, including but not limited to: integrated scale, bed exit system, integrated bed extender, fixed or foldable IV pole, patient helper, oxygen bottle holder and extension cushions. The expected life under normal usage and maintenance is 10 years. The ook snow is designed for use in the following environments: intensive and critical care, acute care, outpatient care, professional long term care and, recovery or therapeutic areas. The product can be used for patient transportation between bays and procedural rooms. The overall capacity of the bed goes up to 600 lb. The bed is designed for the use of one single person and, to be used with a sleep surface. The patient sleep surface can be 80" long or, up to 84" or 90" with an integrated bed extender and cushion. Users are health care providers, bystanders, maintenance staff and the patient. Lockout of siderails controls can limit patient access to functionalities.
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 | 00670482000104 | GS1 | ||||
| Previous | 00670482000067 | GS1 | ||||
| Package | 10670482000101 | GS1 | 1 | In Commercial Distribution |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 158 Degrees Fahrenheit