Duns Number:315654579
Device Description: For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path. For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path.
Catalog Number
4C2304
Brand Name
Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter
Version/Model Number
4C2304
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
BK000039,BK000039,BK000039
Product Code
GKT
Product Code Name
Separator, Automated, Blood Cell, Diagnostic
Public Device Record Key
ef6f0186-371b-4ded-a6a9-1388d38cbb87
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 18, 2017
Package DI Number
M5264C23043
Quantity per Package
6
Contains DI Package
M5264C23041
Package Discontinue Date
-
Package Status
-
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 |