Duns Number:062312574
Device Description: Body Analysis Scale
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
275172
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)
Yes
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
3f99f6bb-23e3-4e4f-86a6-600f36e501f0
Public Version Date
August 14, 2018
Public Version Number
3
DI Record Publish Date
October 11, 2016
Package DI Number
10050428414597
Quantity per Package
4
Contains DI Package
00050428414590
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 82 |
2 | A medical device with a moderate to high risk that requires special controls. | 139 |
U | Unclassified | 23 |