Duns Number:260119720
Catalog Number
-
Brand Name
Withings®
Version/Model Number
WBS05-Pastel Green
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUH
Product Code Name
Analyzer, Body Composition, Exempt
Public Device Record Key
1964fb5e-552f-47e7-83f1-2dfb2e7189bc
Public Version Date
February 28, 2020
Public Version Number
2
DI Record Publish Date
October 31, 2018
Package DI Number
13700546705097
Quantity per Package
4
Contains DI Package
03700546705090
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 5 |