Duns Number:249675476
Device Description: The ook snow is an AC-powered medical bed that offers an optional bed status monitoring sy The ook snow is an AC-powered medical bed that offers an optional bed status monitoring system. The bed maximum safe working load is of 600lb.
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
50118526-a456-4f56-9dda-d3ae59dc2a77
Public Version Date
March 26, 2019
Public Version Number
1
DI Record Publish Date
March 18, 2019
Package DI Number
10670482000187
Quantity per Package
1
Contains DI Package
00670482000180
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 |