Duns Number:066761271
Device Description: George King Factor XII Deficient Plasma is fresh frozen citrated human plasma derived from George King Factor XII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor XII Deficient donors
Catalog Number
-
Brand Name
George King Factor XII Deficient Plasma
Version/Model Number
1200-1.0
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
GJT
Product Code Name
Plasma, Coagulation Factor Deficient
Public Device Record Key
0d42ae2c-4c78-4f18-a015-c3ae3656e5e1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 22, 2016
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 |