Duns Number:790937150
Device Description: WeCare Response Bed, Manual, No Panels
Catalog Number
WECC-RESP-BD
Brand Name
WeCare Response Bed
Version/Model Number
WECC-RESP-BD
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
FNJ
Product Code Name
Bed, Manual
Public Device Record Key
91fb9579-9cac-421b-8f16-44505e1d7ee9
Public Version Date
September 29, 2020
Public Version Number
1
DI Record Publish Date
September 21, 2020
Package DI Number
20810055880168
Quantity per Package
5
Contains DI Package
00810055880164
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
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 |