ACTtrac®

GUDID 00643169178434

CONSOLE 31363 ACTTRAC CE IVDD

MEDTRONIC, INC.

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

• Primary Device ID: 00643169178434
• NIH Device Record Key: fd1dba4e-d78b-4ac5-9b9b-6764996f9d47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTtrac®
• Version Model Number: 31363
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169178434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940426

FDA Product Code

• GKN: Timer, clot, automated

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: 2016-04-28

On-Brand Devices [ACTtrac®]

• 00613994495167: CONSOLE 31363 ACTTRAC HEPARIN MNGMNT 13L
• 00643169178434: CONSOLE 31363 ACTTRAC CE IVDD
• 00763000135461: CONSOLE 31363 ACTTRAC CE IVDD NON-ROHS