GUDID 00763000108281

MOTOR 560A EXTERNAL DRIVE LONG PLX

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 00763000108281
• NIH Device Record Key: 3613e2bc-393a-4a0e-a88d-908602d4afc1
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000108281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100631

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: 2019-03-15
• Device Publish Date: 2019-03-07

Devices Manufactured by MEDTRONIC, INC.

• 00763000180010 - Sprint Quattro Secure S™: 2024-11-12 LEAD 693552 SPRINT US RCMCRD
• 00763000180027 - Sprint Quattro Secure S™: 2024-11-12 LEAD 693575 SPRINT US RCMCRD
• 00763000180034 - Sprint Quattro Secure S™: 2024-11-12 LEAD 6935100 SPRINT US RCMCRD
• 00763000180041 - Sprint Quattro Secure S MRI™ SureScan™: 2024-11-12 LEAD 693558 SPRINT MRI US RCMCRD
• 00763000180058 - Sprint Quattro Secure S MRI™ SureScan™: 2024-11-12 LEAD 693565 SPRINT MRI US RCMCRD
• 00763000180119 - Sprint Quattro Secure S MRI™ SureScan™: 2024-11-12 LEAD 6935M55 MRI US DF4 RCMCRD
• 00763000180126 - Sprint Quattro Secure S MRI™ SureScan™: 2024-11-12 LEAD 6935M62 MRI US DF4 RCMCRD
• 00763000180133 - Sprint Quattro Secure S™: 2024-11-12 LEAD 6935M49 US DF4 RCMCRD