Duns Number:439770017
Device Description: Disposable ECG electrodes with solid gel, round-shaped Ø 40mm, Silver/Silver Chloride(SSC Disposable ECG electrodes with solid gel, round-shaped Ø 40mm, Silver/Silver Chloride(SSC) sensor and stainless steel snap. F2080P model is is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use. F2080P is suitable for rest, long term, stress or Holter ECG recording, with a direct application onto
Catalog Number
F2080P
Brand Name
NA
Version/Model Number
F2080P
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
fb874837-35df-46b8-9781-3acebffdf494
Public Version Date
November 18, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
Package DI Number
18054242448181
Quantity per Package
24
Contains DI Package
08054242448184
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 |