CLOTtrac™

GUDID 20763000014869

CONTROL 550-12 CLOTTRAC HTC 15BX

MEDTRONIC, INC.

Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control

• Primary Device ID: 20763000014869
• NIH Device Record Key: ae749d97-064f-4afb-bda0-5f72b8064705
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLOTtrac™
• Version Model Number: 550-12
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 15
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000014865 [Unit of Use]
GS1	20763000014869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062348

FDA Product Code

• JBP: ACTIVATED WHOLE BLOOD CLOTTING TIME

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-06

On-Brand Devices [CLOTtrac™]

• 20763000014876: CONTROL 550-13 CLOTTRAC HR 11L 30PK
• 20763000014869: CONTROL 550-12 CLOTTRAC HTC 15BX
• 20763000014852: CONT 550-10 CLOTTRAC RACT ABN 11L 15BX
• 20763000014845: CONT 550-09 CLOTTRAC LR ABN BXD ASY 15BX
• 20763000014838: CONT 550-08 CLOTTRAC HR ABN BXD ASY 15BX
• 20763000014821: CONTROL 550-07 CLOTTRAC HR 11L 15BX
• 20763000014814: CONTROL 550-01 CLOTTRAC CWB 11L 15BX