Duns Number:021842273
Device Description: Package contains 100 adhesive electrodes, sufficient for performing 25 BIA tests for whole Package contains 100 adhesive electrodes, sufficient for performing 25 BIA tests for whole-body body composition analysis.
Catalog Number
92500P
Brand Name
BIA Electrodes
Version/Model Number
92500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
For Single-Use
Yes
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
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
cc3a5c9c-b344-41de-8d9b-fb51fedf6cfd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 01, 2017
Package DI Number
B202925004
Quantity per Package
10
Contains DI Package
B202925003
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |