Haemonetics® NexSys PCS® System

GUDID 00812747019807

Persona™ Plasma Pooling Bottles

HAEMONETICS CORPORATION

Apheresis system tubing set

• Primary Device ID: 00812747019807
• NIH Device Record Key: 6eec5bf4-83d3-4e96-9a00-9b2d64919fa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Haemonetics® NexSys PCS® System
• Version Model Number: 0699S-12
• Company DUNS: 057827420
• Company Name: HAEMONETICS CORPORATION
• Device Count: 12
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812747019807 [Unit of Use]
GS1	30812747019808 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK020001

FDA Product Code

• KSR: CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-18
• Device Publish Date: 2024-10-10

On-Brand Devices [Haemonetics® NexSys PCS® System]

• 30812747019228: Persona™ Plasma Pooling Bottles
• 00812747019807: Persona™ Plasma Pooling Bottles