GUDID 20613994697169

CRTG 304-01POR PORCINE HMS RED 5L 9PK

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic

• Primary Device ID: 20613994697169
• NIH Device Record Key: 393a75fe-5036-49a5-814a-ee69048e4a0f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 304-01POR
• 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	00613994697165 [Unit of Use]
GS1	20613994697169 [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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• 00763000984007 - NA: 2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG
• 00763000984021 - NA: 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE
• 00763000984151 - NA: 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT
• 00763000984168 - NA: 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS
• 00763000984175 - NA: 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK