HAEMONETICS CARDIOPAT SYSTEMS

GUDID 30812747017316

CPAT QUICKCONNECT PROCESS SET

HAEMONETICS CORPORATION

Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set

• Primary Device ID: 30812747017316
• NIH Device Record Key: 0ad159bc-89ce-49ff-8e3c-5efa9bc9aa07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS CARDIOPAT SYSTEMS
• Version Model Number: CPT-P-274
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +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 Dimensions

• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter
• Total Volume: 400 Milliliter
• Total Volume: 3 Liter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812747017312 [Primary]
GS1	30812747017316 [Package]; Contains: 10812747017312; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043127

FDA Product Code

• CAC: Apparatus, Autotransfusion

Sterilization

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

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

On-Brand Devices [HAEMONETICS CARDIOPAT SYSTEMS]

• 30812747017323: CPAT QUICKCONNECT RESERVOIR
• 30812747017316: CPAT QUICKCONNECT PROCESS SET
• 30812747016180: CARDIOPAT POST-OP LINE