Duns Number:439770017
Device Description: Disposable ECG electrodes, round-shaped Ø 40,Silver/Silver Chloride(SSC) sensor and stai Disposable ECG electrodes, round-shaped Ø 40,Silver/Silver Chloride(SSC) sensor and stainless steel snap. The external surface is made of cloth tape. F2060P model is suitable for rest ECG recording, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording
Catalog Number
F2060P
Brand Name
NA
Version/Model Number
F2060P
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
fa0d0077-5640-4480-90f8-123084a1e7cc
Public Version Date
November 18, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
Package DI Number
18033695725933
Quantity per Package
24
Contains DI Package
08033695725936
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 |