ook snow MH
Basic Information
- Brand Name
- ook snow MH
- Primary DI
- 00670482000135
- Version / Model
- FL36 ook snow MH
- 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
- 8fc98ba3-86fe-4c36-a7ba-6466c6876a78
Device Description
The ook snow MH is designed for mental health environment and 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, control boards and tamperproof fasteners. 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, floor fixation and, siderails and boards without openings. The expected life under normal usage and maintenance is 10 years. The ook snow MH is adapted to mental health environment and is designed for use with patients that may have special safety needs, such as patients with mental illness, for procedures, therapy and recovery in adapted health care environments, including, but not limited to, outpatient care, rehabilitation centers and, recovery or therapeutic areas. Some features, such as the adjustable power cord length, are intended for patients with special safety needs. The product can be used for patient transportation between bays and procedural rooms. The overall capacity of the bed goes up to is 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, which can use all bed operations, patient and bystanders, which can use bed motion functions, and maintenance staff.
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 | 00670482000135 | GS1 | ||||
| Previous | 00670482000098 | GS1 | ||||
| Package | 10670482000132 | 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