HAEMONETICS SMARTSUCTION HARMONY SYSTEM

GUDID 30812747017347

VACUUM LINE, UNFILTERED

HAEMONETICS CORPORATION

Red blood cell-recovery autotransfusion system set

• Primary Device ID: 30812747017347
• NIH Device Record Key: 15032163-c571-49dc-82a1-a10fe3c91a7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS SMARTSUCTION HARMONY SYSTEM
• Version Model Number: HAR-A-1001
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 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
• 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	10812747017343 [Primary]
GS1	30812747017347 [Package]; Contains: 10812747017343; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052626

FDA Product Code

• BTA: Pump, Portable, Aspiration (Manual Or Powered)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-01-08
• Device Publish Date: 2015-09-24

Devices Manufactured by HAEMONETICS CORPORATION

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• 30812747014100 - HAEMONETICS CELL SAVER ELITE+ SYSTEM: 2025-06-20
• 00812747018596 - Antiplatelet Reagent: 2025-05-28 ANTIPLATELET REAGENT, US
• 00812747019807 - Haemonetics® NexSys PCS® System: 2024-10-18 Persona™ Plasma Pooling Bottles
• 30812747019273 - Haemonetics® PCS®2 & NexSys PCS® Systems: 2024-07-29 PLS HARNESS SET
• 30812747019341 - Haemonetics® PCS®2 & NexSys PCS® Systems: 2024-07-29 PLS HARNESS SET
• 30812747019730 - Haemonetics® NexSys PCS® System: 2024-07-25 0625Q-00 Plasma Bowl
• 20812747018538 - Global Hemostasis - HN: 2024-04-18 CITRATED: K, KH, RTH, FFH