Duns Number:066761271
Device Description: The George King Coumadin® Plasma Kit is a convenience control kit that contains citrated h The George King Coumadin® Plasma Kit is a convenience control kit that contains citrated human fresh frozen plasma from donors on Coumadin® therapy. Each kit contains control material with six different INR levels.
Catalog Number
-
Brand Name
George King Coumadin® Plasma Convenience Kit
Version/Model Number
0090-30
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"
-
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
GGN
Product Code Name
Plasma, Coagulation Control
Public Device Record Key
30631cd2-1023-4562-b122-013527d5b15c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 24, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 120 |