PXL 12 High Efficiency Leukocyte Reduction Filter

GUDID 30887691000493

PXL 12 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Extension Tubing

HAEMONETICS CORPORATION

Blood transfusion filter
Primary Device ID30887691000493
NIH Device Record Key2230337c-4617-46ba-b398-0d53716ab2cb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePXL 12 High Efficiency Leukocyte Reduction Filter
Version Model NumberPXL12C
Company DUNS057827420
Company NameHAEMONETICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110887691000499 [Primary]
GS130887691000493 [Package]
Contains: 10887691000499
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAKMicrofilter, blood transfusion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-15

On-Brand Devices [PXL 12 High Efficiency Leukocyte Reduction Filter ]

30887691000509PXL 12 High Efficiency Leukocyte Reduction Filter with Attached Straight Administration Set
30887691000493PXL 12 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Extension Tubing

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.