Duns Number:066761271
Device Description: George King CFD is a Congenital Factor Deficient Convenience Kit which contains five diffe George King CFD is a Congenital Factor Deficient Convenience Kit which contains five different factor deficient plasma's for product evaluation
Catalog Number
-
Brand Name
George King Congential Factor Deficiency Convenience Kit
Version/Model Number
0055-5
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
89a1184f-a034-4f1d-9ead-8dd27ae0b197
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 20, 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 |