Duns Number:080935429
Device Description: Integrated Serum Separator Tube,Red/Gray Stopper, 6.0 mL Draw
Catalog Number
8881302106
Brand Name
Corvac
Version/Model Number
8881302106
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 31, 2021
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
c982177d-d5a4-44df-b28a-ca9f4b1f591c
Public Version Date
November 10, 2021
Public Version Number
11
DI Record Publish Date
October 13, 2016
Package DI Number
10884527003198
Quantity per Package
100
Contains DI Package
20884527003195
Package Discontinue Date
May 03, 2021
Package Status
Not in Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |