GUDID 00763000244873

MOTOR 560A EXTERNAL DRIVE SC SPCTRM PLX

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 00763000244873
• NIH Device Record Key: 6b7f3fbe-f53a-4b32-bfeb-cdfba20b5a0b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 560A
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000244873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191077

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-15
• Device Publish Date: 2020-05-07

Devices Manufactured by MEDTRONIC, INC.

• 20199150023800 - NA: 2025-06-09 CUSTOM PACK BB11X70R1 5PK AV LOOP
• 20199150023824 - NA: 2025-06-09 CUSTOM PACK BB8A44R4 4PK HBC MYO
• 20199150024135 - NA: 2025-06-09 CUSTOM PACK BB11A07R2 5PK BRIDGE LINE
• 00613994163523 - Duran AnCore: 2025-06-09 TOOL 7620HXL HANDLE DURAN ANCORE 14L
• 00613994959546 - Open Pivot™: 2025-06-09 ACCY 558 ACTUATOR PACKAGE AVG
• 00643169402539 - MOSAIC ULTRA™: 2025-06-09 SIZERS 7308U MOSAIC ULTRA AORTIC 26L
• 00643169402591 - MOSAIC™CINCH™: 2025-06-09 SIZERS 7308C MOSAIC CINCH AORTIC 26L
• 00643169525511 - CG Future™: 2025-06-09 SIZER SET 7638S CG FUTURE 26L