Duns Number:049529118
Catalog Number
-
Brand Name
Universal CE electrode-patch
Version/Model Number
02-01639
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"
-
For Single-Use
Yes
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
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
4d08f428-2cce-4089-af88-de7379f687b0
Public Version Date
February 16, 2022
Public Version Number
4
DI Record Publish Date
October 04, 2019
Package DI Number
B146PE2C1
Quantity per Package
40
Contains DI Package
B146PE2C0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 122 |