Duns Number:001315134
Device Description: Body Fat Monitoring Scale
Catalog Number
-
Brand Name
Health-O-Meter
Version/Model Number
BFM081DQ1-63
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
MNW
Product Code Name
Analyzer, Body Composition
Public Device Record Key
6fb2d24c-36f9-4958-a1be-c6ccd083c314
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 04, 2016
Package DI Number
20080006112338
Quantity per Package
2
Contains DI Package
00080006112334
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 | 23 |
2 | A medical device with a moderate to high risk that requires special controls. | 164 |