Duns Number:066761271
Device Description: George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated human pla George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor who has developed an antibody to FVIII.
Catalog Number
-
Brand Name
George King Factor VIII Deficient Plasma with Inhibitor
Version/Model Number
1800-1.0
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
GGC
Product Code Name
Control, Plasma, Abnormal
Public Device Record Key
6f506498-0244-4685-a76f-8e7b0d46a85d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 18, 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 |