Duns Number:057827420
Device Description: PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Extension Set
Catalog Number
-
Brand Name
PXL 8
Version/Model Number
PXL8C
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
K873667,K873667
Product Code
CAK
Product Code Name
Microfilter, blood transfusion
Public Device Record Key
e9981183-e21d-4b6f-b539-c29720b9a359
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 12, 2016
Package DI Number
30887691000530
Quantity per Package
20
Contains DI Package
10887691000536
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 |