CLOTtrac®

GUDID 20613994923343

BOXED 550-12 CLOTTRAC HTC CONTROL

MEDTRONIC, INC.

Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control

• Primary Device ID: 20613994923343
• NIH Device Record Key: f6f53dec-291a-4218-89e5-b3c9aee929f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLOTtrac®
• Version Model Number: 550-12
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 15
• 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

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Upon receipt, the control should be stored refrigerated, from 2° to 10°C, until use. Once reconstituted, the control is stable for 2 hours at room temperature, 15° to 25°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Upon receipt, the control should be stored refrigerated, from 2° to 10°C, until use. Once reconstituted, the control is stable for 2 hours at room temperature, 15° to 25°C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994923349 [Unit of Use]
GS1	20613994923343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042175

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: 2016-06-18

Devices Manufactured by MEDTRONIC, INC.

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• 00763000943844 - NA: 2024-04-12 CUSTOM PACK BB11J59R5 PEDS
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• 00763000943868 - NA: 2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT
• 00763000943899 - NA: 2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD