HAEMONETICS ORTHOPAT ADVANCE SYSTEM

GUDID 30812747017910

ORTHOPAT ADVANCE, LN OPA-E-US

HAEMONETICS CORPORATION

Blood-processing autotransfusion system Blood-processing autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump

• Primary Device ID: 30812747017910
• NIH Device Record Key: 8e661747-acd0-43cb-8aa7-45b9325c74da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS ORTHOPAT ADVANCE SYSTEM
• Version Model Number: OPA-E-US
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: +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
• 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	30812747017910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122262

FDA Product Code

• CAC: Apparatus, Autotransfusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [HAEMONETICS ORTHOPAT ADVANCE SYSTEM]

• 30812747017910: ORTHOPAT ADVANCE, LN OPA-E-US
• 30812747017392: QUICKCONNECT RESERVOIR