PXL 8

GUDID 30887691000530

PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Extension Set

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: 30887691000530
• NIH Device Record Key: e9981183-e21d-4b6f-b539-c29720b9a359
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PXL 8
• Version Model Number: PXL8C
• 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	10887691000536 [Primary]
GS1	30887691000530 [Package]; Contains: 10887691000536; 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: 2016-12-12

On-Brand Devices [PXL 8]

• 30887691000554: PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Y-Type Administrati
• 30887691000530: PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Extension Set