Duns Number:080935429
Device Description: True content to be populated as part of rebranding
Catalog Number
8881302015
Brand Name
Corvac
Version/Model Number
8881302015
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 13, 2022
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"
-
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
GIM
Product Code Name
Tubes, vacuum sample, with anticoagulant
Public Device Record Key
21f522d8-4f77-4348-a05a-591c250463e9
Public Version Date
May 13, 2022
Public Version Number
5
DI Record Publish Date
May 17, 2019
Package DI Number
10884521742420
Quantity per Package
5
Contains DI Package
20884521742427
Package Discontinue Date
May 13, 2022
Package Status
Not 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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |