Duns Number:002111896
Device Description: Packed for McKesson General Medical, Tempe AZ 8526325 KITS PER CASE
Catalog Number
GENEAZ-1
Brand Name
Vermed Holter Kit
Version/Model Number
GENEAZ-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 12, 2019
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
-
Product Code Name
-
Public Device Record Key
fe50e59b-fa37-46a1-8eeb-dcc6f63fe518
Public Version Date
December 13, 2019
Public Version Number
3
DI Record Publish Date
April 14, 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 |