Duns Number:794519020
Device Description: SEPACELL Pre-Storage Leukocyte Reduction Set for Red Cells. Sterile Fluid Path
Catalog Number
4C2300
Brand Name
NA
Version/Model Number
4C2300
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
BK980041,BK980041
Product Code
CAK
Product Code Name
Microfilter, Blood Transfusion
Public Device Record Key
6d460985-42f4-43b3-8ea8-5b586c2902d2
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
September 12, 2016
Package DI Number
10811137010469
Quantity per Package
18
Contains DI Package
00811137010462
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |