Duns Number:757258843
Device Description: Body Composition Dual Tab Electrode, each pouch contains 60 single use gel backed electrod Body Composition Dual Tab Electrode, each pouch contains 60 single use gel backed electrodes.
Catalog Number
292-BCE
Brand Name
Body Composition Dual Tab Electrode
Version/Model Number
292-BCE
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
1ee3eac9-1f5e-4384-b37f-c8971d367248
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 13, 2017
Package DI Number
B277292BCE2
Quantity per Package
10
Contains DI Package
B277292BCE1
Package Discontinue Date
-
Package Status
-
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |