Duns Number:439770017
Device Description: Disposable ECG electrodes, oval-shaped 48x34mm dimensions with solid gel, Silver/Si Disposable ECG electrodes, oval-shaped 48x34mm dimensions with solid gel, Silver/Silver Chloride (SSC) sensor and stainless steel snap. F9049/100 model is suitable for rest, long term, stress or Holter ECG recording, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids.
Catalog Number
F9049/100
Brand Name
NA
Version/Model Number
F9049/100
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
80ed4058-6b4e-4b3e-95e7-8326cc49667a
Public Version Date
November 18, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
Package DI Number
18054242449089
Quantity per Package
20
Contains DI Package
08054242449082
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 |