HEPline®

GUDID 00763000014902

LINEARITY KIT 313-50 HEPLINE

MEDTRONIC, INC.

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

Devices Manufactured by MEDTRONIC, INC.

• 00199150000012 - NA: 2025-03-07 CUSTOM PACK BB10J80R7 1/4CNTRI
• 00763000997984 - NA: 2025-03-07 CUSTOM PACK BB11F56R9 PEDS V
• 00763000999346 - NA: 2025-03-07 CUSTOM PACK BB3R67R6 SU AVLOOP
• 20763000999364 - NA: 2025-03-07 CUSTOM PACK BB8A42R1 2PK TAVR PACK
• 20763000999388 - NA: 2025-03-07 CUSTOM PACK BB3J83R2 5PK 38X332X16
• 20763000999401 - NA: 2025-03-07 CUSTOM PACK BB11J01R1 5PK BRIDGE SUP
• 00763000999513 - NA: 2025-03-07 CUSTOM PACK BB11F41R3 ADLT SUPP PAC
• 20763000999777 - NA: 2025-03-07 CUSTOM PACK BB12M84R1 10PK 3/8 SUPP LINE