Duns Number:315654579
Device Description: For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma Product by For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma Product by Centrifugation. For Use with the ALYX System. Sterile Fluid Path.
Catalog Number
X4R5700
Brand Name
ALYX RBC/PLASMA KIT
Version/Model Number
X4R5700
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
BK040084,BK040084
Product Code
GKT
Product Code Name
Separator, Automated, Blood Cell, Diagnostic
Public Device Record Key
2e3418eb-684b-4e3e-af88-bcb0a178b0af
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 14, 2018
Package DI Number
14086000101001
Quantity per Package
6
Contains DI Package
04086000101004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 2 |