HAEMONETICS CELL SAVER SYSTEM

GUDID 10812747016063

RESERVOIR, HARD-SHELL, 20µ_ Additional packaging DI: 20812747016060, Unit packaging, contains (1) 1082747016063

HAEMONETICS CORPORATION

Red blood cell-recovery autotransfusion system set

• Primary Device ID: 10812747016063
• NIH Device Record Key: 7771d752-8568-4480-96f8-1c92c44d6eab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS CELL SAVER SYSTEM
• Version Model Number: 00220-00
• 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: +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

• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812747016063 [Primary]
GS1	20812747016060 [Package]; Package: Unit [1 Units]; In Commercial Distribution
GS1	30812747016067 [Package]; Contains: 20812747016060; Package: Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932890

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: 2017-06-16

On-Brand Devices [HAEMONETICS CELL SAVER SYSTEM]

• 30812747016340: CELL SAVER STEP DOWN ADAPTER
• 30812747016074: Y SET WITH EXTENSION LINE
• 10812747016063: RESERVOIR, HARD-SHELL, 20µ_ Additional packaging DI: 20812747016060, Unit packaging, contains (
• 30812747016043: ASPIRATION/ANTICOAGULATION SET
• 30812747016036: RESERVOIR,HARDSHELL,150 µ_ Note: Additional packaging DI: 20812747016039, Unit Packaging, conta
• 10812747016025: Y CONNECTOR WITH CHECK VALVE