GUDID 20613994697206

CRTG 304-05POR PORC HMS BLU 5L INT 9PK

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic

• Primary Device ID: 20613994697206
• NIH Device Record Key: 7026df76-bb17-4930-88f0-7abe27e1a92d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 304-05POR
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 9
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated 2°C-10°C
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature 10°C-25°C
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated 2°C-10°C
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature 10°C-25°C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994697202 [Unit of Use]
GS1	20613994697206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894317

FDA Product Code

• JOX: ANALYZER, HEPARIN, 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: 2016-06-13

Devices Manufactured by MEDTRONIC, INC.

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• 00763000747473 - NA: 2026-02-17 CATHETER C320LBBS45 SMALL CURVE 45 GBL
• 00763000747480 - NA: 2026-02-17 CATHETER C320LBBS48 SMALL CURVE 48 GBL
• 00199150068814 - NA: 2026-02-16 CUSTOM PACK BB6M71R13 EVL CP PRIME
• 20199150068832 - NA: 2026-02-16 CUSTOM PACK BB12T52R 5PK ACC CPG LINE
• 20199150069105 - NA: 2026-02-16 CUSTOM PACK BB12A17R1 5PK ACC XTR SUCKR
• 00199150069514 - NA: 2026-02-16 CUSTOM PACK BB5V41R24 HLO OCPA 1