Duns Number:690539978
Catalog Number
BC-401F BK
Brand Name
TANITA/FitScan Body Composition Monitor
Version/Model Number
BC-401F
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
PUH
Product Code Name
Analyzer, Body Composition, Exempt
Public Device Record Key
cd0a65ea-3a0a-4088-a1a0-9a24f19ba978
Public Version Date
October 19, 2020
Public Version Number
1
DI Record Publish Date
October 09, 2020
Package DI Number
14904785047621
Quantity per Package
5
Contains DI Package
04904785047624
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. | 47 |