Duns Number:057827420
Device Description: High Efficiency Leukocyte Reduction Filter for Platelets with Attached Straight Administra High Efficiency Leukocyte Reduction Filter for Platelets with Attached Straight Administration Set
Catalog Number
-
Brand Name
Haemonetics
Version/Model Number
PXL8K
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
-
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
31372368-5b75-4706-922a-58320abdc558
Public Version Date
March 23, 2022
Public Version Number
1
DI Record Publish Date
March 15, 2022
Package DI Number
30887691000547
Quantity per Package
20
Contains DI Package
10887691000543
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 |