GUDID 20613994923275

CRTG 304-20POR PORC HDR 5L INT 9BX

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic

• Primary Device ID: 20613994923275
• NIH Device Record Key: 01f26278-1223-45b0-aede-d71aa1b5b082
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 304-20POR
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994923271 [Unit of Use]
GS1	20613994923275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894317

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: 2016-07-29

Devices Manufactured by MEDTRONIC, INC.

• 00763000959616 - AEX: 2025-04-04 AEX GENERATOR 40-405-1R REFURB US
• 20763000651736 - Aortic Punch: 2025-03-31 Aortic Punch APU425 - 2.5mm punch size
• 20763000651743 - Aortic Punch: 2025-03-31 Aortic Punch APU430 - 3.0mm punch size
• 20763000651750 - Aortic Punch: 2025-03-31 Aortic Punch APU435 - 3.5mm punch size
• 20763000651767 - Aortic Punch: 2025-03-31 Aortic Punch APU440 - 4.0mm punch size
• 20763000651774 - Aortic Punch: 2025-03-31 Aortic Punch APU444 - 4.4mm punch size
• 20763000651781 - Aortic Punch: 2025-03-31 Aortic Punch APU448 - 4.8mm punch size
• 20763000651798 - Aortic Punch: 2025-03-31 Aortic Punch APU450 - 5.0mm punch size