Duns Number:057827420
Device Description: Leukocyte Reduction Filter System for Red Blood Cells with BPF4 High Efficiency Filter, 16 Leukocyte Reduction Filter System for Red Blood Cells with BPF4 High Efficiency Filter, 16-Segment Tubing, Storage Bag and Sample Pouch
Catalog Number
-
Brand Name
Leukocyte SC RC
Version/Model Number
430-40
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"
Yes
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
BK050015,BK050015
Product Code
CAK
Product Code Name
Microfilter, blood transfusion
Public Device Record Key
56aa0691-89f3-4062-b4f6-219706e4034b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 16, 2017
Package DI Number
30887691308742
Quantity per Package
4
Contains DI Package
20887691308745
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |
| U | Unclassified | 2 |