Duns Number:790937150
Device Description: JOERNS WECARE FULL-ELEC HILO BED-BASE
Catalog Number
WECC-WECARE-BASE
Brand Name
WeCare Response Bed
Version/Model Number
WECC-WECARE-BASE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
f3d71d7b-e6ca-4bf2-a9df-39f2b91d793a
Public Version Date
April 15, 2022
Public Version Number
1
DI Record Publish Date
April 07, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 164 |
2 | A medical device with a moderate to high risk that requires special controls. | 131 |