GUDID 00673978519173

CONTROL TEST 550-90 PROFICIENCY 5L

MEDTRONIC, INC.

Multiple coagulation factor IVD, control

• Primary Device ID: 00673978519173
• NIH Device Record Key: 47631db9-d1c4-4ab4-8701-a31cfa59dbb8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 550-90
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00673978519173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894359

FDA Product Code

• JPA: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-11

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