Duns Number:002111896
Device Description: ICG SENSOR AND CABLE SYSTEM2 dual electrodes/pouch, 50 pch/case, 200/case
Catalog Number
BZ-4550-50
Brand Name
BioZ Advasense by Vermed
Version/Model Number
BZ-4550-50
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
1c9693ee-c6f1-4c71-9c42-bd58d4df4dd3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 31, 2017
Package DI Number
20813150022358
Quantity per Package
50
Contains DI Package
10813150022351
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 |