HEPtrac®

GUDID 00613994615633

DEVICE 313-51 HEPTRAC ELEC QLT CNTRL CEM

MEDTRONIC, INC.

Coagulation timer IVD

• Primary Device ID: 00613994615633
• NIH Device Record Key: 74190b82-e470-495c-89e8-d5d73a92687d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEPtrac®
• Version Model Number: 313-51
• 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

• Storage Environment Temperature: Between -50 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -50 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -50 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -50 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994615633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981815

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: 2016-09-04

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