Duns Number:439770017
Device Description: F9047 model is ECG disposable pregelled electrode with liquid, 32x44mm dimensions, SSC sen F9047 model is ECG disposable pregelled electrode with liquid, 32x44mm dimensions, SSC sensor and clip connection. The ECG electrode have features that make them absolutely reliable during signal recording. F9047 model is used also recording in stress test and for Holter monitoring.
Catalog Number
F9047
Brand Name
NA
Version/Model Number
F9047
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
b4afd20c-8f7d-4cb5-80c3-c8be9387024b
Public Version Date
November 18, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
Package DI Number
38033695725418
Quantity per Package
24
Contains DI Package
08033695725417
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 |