GUDID 20643169713264

CARTRIDGE 402-07 HR HTC BXD 11L 20BX

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic

• Primary Device ID: 20643169713264
• NIH Device Record Key: 3584dbd6-ca9a-48d5-8fad-ba854ec8d992
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 402-07
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 20
• 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

• Special Storage Condition, Specify: Between 0 and 0 *The HR HTC should be stored in a stable environment, either at
• Special Storage Condition, Specify: Between 0 and 0 *The HR HTC should be stored in a stable environment, either at

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169713260 [Unit of Use]
GS1	20643169713264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902081

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-25

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