GUDID 20673978523570

CARDIOTOMY EL400 4 LITER 120 MICRON

MEDTRONIC, INC.

Cardiotomy reservoir

• Primary Device ID: 20673978523570
• NIH Device Record Key: e96ba8b9-eb74-4e1c-9f5c-56526dac97e5
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: EL400
• 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: 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

Device Dimensions

• Pore Size: 120 Micrometer
• Pore Size: 120 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978523576 [Primary]
GS1	20673978523570 [Package]; Contains: 00673978523576; Package: PK [6 Units]; Discontinued: 2018-10-05; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926250

FDA Product Code

• DTN: RESERVOIR, BLOOD, 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: 5
• Public Version Date: 2020-01-22
• Device Publish Date: 2016-06-16

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