Duns Number:265492868
Device Description: Leucolab LCG2b Leukoreduction System for Red Blood Cells. The Leucolab LCG2b product cons Leucolab LCG2b Leukoreduction System for Red Blood Cells. The Leucolab LCG2b product consists of a transfer line, drip chamber, leukoreduction filter, by-pass tubing and transfer bag. It is sterilized by electron beam (beta irradiation) and is supplied with sterile and non-pyrogenic fluid pathways.
Catalog Number
KSV0004XD
Brand Name
LCG2b with AS-1, AS-3 and AS-5
Version/Model Number
KSV
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
BK120071,BK120071
Product Code
CAK
Product Code Name
Microfilter, Blood Transfusion
Public Device Record Key
7294307a-0a17-4ad9-94e8-b3442db6bf8b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
13567050035344
Quantity per Package
15
Contains DI Package
03567050035347
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |