Duns Number:690539978
Catalog Number
-
Brand Name
TANITA Digital Baby Scale
Version/Model Number
BD-585
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
60e0357a-b568-4fd0-a9b7-7b62b68d32a0
Public Version Date
January 01, 2020
Public Version Number
1
DI Record Publish Date
December 24, 2019
Package DI Number
14904785043654
Quantity per Package
2
Contains DI Package
04904785043657
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 |