PXL 12 High Efficiency Leukocyte Reduction Filter

GUDID 30887691000509

PXL 12 High Efficiency Leukocyte Reduction Filter with Attached Straight Administration Set

HAEMONETICS CORPORATION

Blood transfusion filter

• Primary Device ID: 30887691000509
• NIH Device Record Key: 8818f4ba-6896-4f9f-9efd-f7e9bed2e90c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PXL 12 High Efficiency Leukocyte Reduction Filter
• Version Model Number: PXL12K
• 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	10887691000505 [Primary]
GS1	30887691000509 [Package]; Contains: 10887691000505; 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