Duns Number:002111896
Device Description: 5 PER POUCH, 200 POUCHES PER CASE, 1000/CASE
Catalog Number
6503000V
Brand Name
Z-Brand™
Version/Model Number
Z05SGRT-5NB USA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2020
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
f27eb6bc-358d-4c99-8aee-083e556ccc9e
Public Version Date
December 02, 2020
Public Version Number
3
DI Record Publish Date
April 07, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |