Duns Number:249675476
Device Description: The ook snow MH, model FL36, is an AC-powered medical bed with 4 built-in electric DC actu The ook snow MH, model FL36, is an AC-powered medical bed with 4 built-in electric DC actuators and controls that is intended for medical purposes in mental health care units and/or environments. The maximum safe working load of the bed is of 600lb and a service life of 15 years.
Catalog Number
FL36
Brand Name
ook snow MH
Version/Model Number
FL36 ook snow MH
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
46383e7a-c685-4830-a0a4-7458187eddcd
Public Version Date
June 14, 2021
Public Version Number
1
DI Record Publish Date
June 04, 2021
Package DI Number
10670482000514
Quantity per Package
1
Contains DI Package
00670482000517
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 |