Duns Number:439770017
Device Description: Disposable ECG monitoring electrodes have features that make them absolutely r
Catalog Number
F9053PR
Brand Name
NA
Version/Model Number
F9053PR
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
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
34097ca1-ef80-4f8e-8207-5421752c0145
Public Version Date
November 11, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
Package DI Number
18054242445913
Quantity per Package
5
Contains DI Package
08054242445916
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. | 42 |