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 Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter

• Primary Device ID: 30887691000493
• NIH Device Record Key: 2230337c-4617-46ba-b398-0d53716ab2cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PXL 12 High Efficiency Leukocyte Reduction Filter
• Version Model Number: PXL12C
• Company DUNS: 057827420
• Company Name: HAEMONETICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887691000499 [Primary]
GS1	30887691000493 [Package]; Contains: 10887691000499; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K873667

FDA Product Code

• CAK: Microfilter, blood transfusion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-15

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

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