Duns Number:439770017
Device Description: Disposable ECG electrodes, round-shaped Ø 50mm, pre-gelled and equipped with snap connect Disposable ECG electrodes, round-shaped Ø 50mm, pre-gelled and equipped with snap connection. F9070 model has features that make it absolutely reliable during signal recording with all different ECG on the market in stress tests and holter.
Catalog Number
F9070
Brand Name
NA
Version/Model Number
F9070
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
1fbaea62-60b6-4e64-a9cc-3bf2068082a3
Public Version Date
November 18, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
Package DI Number
18033695725988
Quantity per Package
24
Contains DI Package
38033695725982
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 |