GUDID 00643169315822

CONSOLE 560BCS1 CONTROL W/SAFETY BRD MEE

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 00643169315822
• NIH Device Record Key: 189a9b64-4d97-4ea2-86f0-fa3f0c8065d4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 560BCS1
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169315822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080824

FDA Product Code

• DWA: Control, pump speed, cardiopulmonary bypass

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: 2015-06-19

Devices Manufactured by MEDTRONIC, INC.

• 00763000747459 - NA: 2026-02-17 CATHETER C320LBBL45 LARGE CURVE 45 GBL
• 00763000747466 - NA: 2026-02-17 CATHETER C320LBBL48 LARGE CURVE 48 GBL
• 00763000747473 - NA: 2026-02-17 CATHETER C320LBBS45 SMALL CURVE 45 GBL
• 00763000747480 - NA: 2026-02-17 CATHETER C320LBBS48 SMALL CURVE 48 GBL
• 00199150006045 - N/A: 2026-02-10 COMM HANDSET KIT TH90D01 DBS EMANUAL US
• 00199150068302 - NA: 2026-02-10 CUSTOM PACK BB12M12R7 HLO CPB
• 20199150068351 - NA: 2026-02-10 CUSTOM PACK 12C75R1 20PK ACC BIDMC-PCK
• 20199150068382 - NA: 2026-02-10 CUSTOM PACK BB12C41R9 10PK ACC LNG PK