GUDID 00763000244866

MOTOR 560A EXTERNAL DRIVE LC SPCTRM PLX

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 00763000244866
• NIH Device Record Key: 81681dc3-b672-49bc-a44e-6455b10e0cd5
• 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 Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000244866 [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.

• 20763000825380 - NA: 2024-11-20 CUSTOM PACK CB12B36R1 4PK DEL NIDO CPG
• 20763000984193 - NA: 2024-11-18 CUSTOM PACK BB12F71R5 4PK LOYOLA CPG
• 20763000982946 - NA: 2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD
• 00763000984007 - NA: 2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG
• 00763000984021 - NA: 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE
• 00763000984151 - NA: 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT
• 00763000984168 - NA: 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS
• 00763000984175 - NA: 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK