Duns Number:249675476
Device Description: The ook cocoon is an AC-powered medical bed with a SWL of 600lb.
Catalog Number
FL36
Brand Name
ook cocoon
Version/Model Number
FL36 ook cocoon
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
c751fd7b-fe49-4bea-8648-c26777c6daa4
Public Version Date
September 19, 2022
Public Version Number
1
DI Record Publish Date
September 09, 2022
Package DI Number
10670482000613
Quantity per Package
1
Contains DI Package
00670482000616
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 |