Duns Number:690539978
Catalog Number
-
Brand Name
TANITA Degital Baby Scale
Version/Model Number
BD-590
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
FRW
Product Code Name
Scale, Patient
Public Device Record Key
1847e09e-d9fc-4fe9-aaa0-bca3ad6badf3
Public Version Date
August 27, 2019
Public Version Number
1
DI Record Publish Date
August 19, 2019
Package DI Number
14904785043579
Quantity per Package
2
Contains DI Package
04904785043572
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 |