GUDID 20721902938003

CANNULA KIT DLP2X20R1 5PK DLP

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 20721902938003
• NIH Device Record Key: e8432b77-b7d7-4e8a-8307-03ceff04db96
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DLP2X20R1
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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
• 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
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902938009 [Primary]
GS1	20721902938003 [Package]; Contains: 00721902938009; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924529

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-22

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