HEPline®

GUDID 00763000014902

LINEARITY KIT 313-50 HEPLINE

MEDTRONIC, INC.

Coagulation timer IVD
Primary Device ID00763000014902
NIH Device Record Keyda0e0d0c-4bd0-4823-b2bc-cf32a0330b7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEPline®
Version Model Number313-50
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Store tubes in the box until the time of use.
Special Storage Condition, SpecifyBetween 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 AgencyDevice ID
GS100763000014902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-31
Device Publish Date2023-07-23

Devices Manufactured by MEDTRONIC, INC.

00199150036998 - NA2025-08-08 CUSTOM PACK BB6H41R30 LESS 20K
00199150037643 - NA2025-08-08 CUSTOM PACK BB4941R6 SUPPORT
00199150037650 - NA2025-08-08 CUSTOM PACK BB12Q72R SEQ ADLT COMBO
00199150037711 - NA2025-08-08 CUSTOM PACK BB7M47R9 ADULT
20199150037739 - NA2025-08-08 CUSTOM PACK BB10M84R3 5PK AVL 3/8
20199150037753 - NA2025-08-08 CUSTOM PACK BB12R03R 20PK ACC 1/4X3/8X3/
00199150037773 - NA2025-08-08 CUSTOM PACK BB9E90R10 3/8 SPRT P
20199150038019 - NA2025-08-08 CUSTOM PACK 7P25R6 4PK CARDPLEGIAM

Trademark Results [HEPline]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEPLINE
HEPLINE
77725273 3698911 Live/Registered
Medtronic, Inc.
2009-04-29
HEPLINE
HEPLINE
75453269 2366844 Dead/Cancelled
Medtronic, Inc.
1998-03-19

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.