Duns Number:439770017
Device Description: F9069PRM model is disposable ECG RADIOLUCENT electrode with solid gel, oval-shaped F9069PRM model is disposable ECG RADIOLUCENT electrode with solid gel, oval-shaped 32x36mm, Silver/Silver Chloride (SSC) sensor and carbon snap.The SSC sensor permits a reliable and stable recording. The peculiar feature of the electrode is the carbon snap that makes it radiolucent. Neither of the components contains any ferromagnetic materials, therefore the electrodes are fully compatible with MRI applications. The electrodes are MRI tested for use up to 3 T electro-magnetic field. The use of the electrodes do not affect the safety and functioning of Magnetic Resonance Imaging Systems. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids
Catalog Number
F9069PRM
Brand Name
NA
Version/Model Number
F9069PRM
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
2762c332-cb91-40a2-be34-f98ef9ca1b8f
Public Version Date
November 18, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
Package DI Number
18033695726503
Quantity per Package
24
Contains DI Package
08033695726506
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 |