GUDID 20613994923329

CONTROL 306-05POR PORC HMS ORANGE 10BX

MEDTRONIC, INC.

Coagulation timer IVD Coagulation timer IVD

• Primary Device ID: 20613994923329
• NIH Device Record Key: 0191ac89-b683-4be0-a625-f47f4f080f2d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 306-05POR
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 10
• 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 *Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C).
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C).
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994923325 [Unit of Use]
GS1	20613994923329 [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: 2016-06-18

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