Duns Number:249675476
Device Description: The ook snow is an AC-powered medical bed with 4 built-in electric DC actuators. The heigh 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.
Catalog Number
FL36
Brand Name
ook snow
Version/Model Number
FL36 ook snow
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FNL
Product Code Name
Bed, Ac-Powered Adjustable Hospital
Public Device Record Key
6fb2d236-9a1a-4098-90cd-d6775d35eddc
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 10, 2018
Package DI Number
10670482000101
Quantity per Package
1
Contains DI Package
00670482000104
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |