Duns Number:529903321
Catalog Number
-
Brand Name
CoachCare
Version/Model Number
S-3
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
a1181ac5-2310-4e46-9be3-eae3173f3ca0
Public Version Date
January 07, 2019
Public Version Number
1
DI Record Publish Date
December 06, 2018
Package DI Number
26947468545606
Quantity per Package
4
Contains DI Package
16947468545609
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
4pcs/box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |