Duns Number:057827420
Device Description: Leukotrap High Efficiency Leukocyte Reduction Filtration System for Red Blood Cells with B Leukotrap High Efficiency Leukocyte Reduction Filtration System for Red Blood Cells with BPF4 Filter
Catalog Number
-
Brand Name
Haemonetics Leukotrap SC RC
Version/Model Number
BPFBLA
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
BK910019,BK910019
Product Code
CAK
Product Code Name
Microfilter, blood transfusion
Public Device Record Key
e076d088-324f-49e0-9690-f2b309563bf8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 19, 2017
Package DI Number
30887691304218
Quantity per Package
50
Contains DI Package
10887691304214
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 |