Duns Number:690539978
Catalog Number
BC-603FS MB
Brand Name
TANITA/FitScan Body Composition Monitor
Version/Model Number
BC-603FS
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
ae50bf56-b803-4b35-9d8b-6a1e8b1dacc1
Public Version Date
November 27, 2020
Public Version Number
1
DI Record Publish Date
November 19, 2020
Package DI Number
14904785047669
Quantity per Package
4
Contains DI Package
04904785047662
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 |