Duns Number:002111896
Device Description: ECG Diagnostic Electrodes1/pouch, 600 pouches/ case, 600/ca
Catalog Number
FT005-REF
Brand Name
MVAP Medical Supplies
Version/Model Number
FT005-REF
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
47c1ee10-1406-4afe-a435-609610648b3e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 14, 2017
Package DI Number
20813150022372
Quantity per Package
600
Contains DI Package
10813150022375
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 269 |
| 3 | A medical device with high risk that requires premarket approval | 1 |