HEPline®

GUDID 00763000014902

LINEARITY KIT 313-50 HEPLINE

MEDTRONIC, INC.

Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD Coagulation timer IVD

• Primary Device ID: 00763000014902
• NIH Device Record Key: da0e0d0c-4bd0-4823-b2bc-cf32a0330b7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEPline®
• Version Model Number: 313-50
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• 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: false
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• 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 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit must be used by the room temperature date or by the printed refrigerated Use- By Date, whichever comes first.
• Special Storage Condition, Specify: Between 0 and 0 *Store tubes in the box until the time of use.
• Special Storage Condition, Specify: Between 0 and 0 *If removed from refrigeration, the kit may be stored at room temperature (10°C to 25°C) for up to 7 days

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000014902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981815

FDA Product Code

• JPA: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-31
• Device Publish Date: 2023-07-23

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