RACT

GUDID 20613994531821

CARTRIDGE 402-02 ACT RACT 14L

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic
Primary Device ID20613994531821
NIH Device Record Key7d70af9c-3da3-4aea-922a-5d6ef960c181
Commercial Distribution Discontinuation2018-10-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRACT
Version Model Number402-02
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994531827 [Unit of Use]
GS120613994531821 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-08
Device Publish Date2016-06-13

On-Brand Devices [RACT]

20643169577484CARTRIDGE 402-02 ACT RACT 13 LAN
20613994531821CARTRIDGE 402-02 ACT RACT 14L
20613994417286CARTRIDGE 402-02 ACT RACT 13 LAN
00763000433833CARTRIDGE 402-02 ACT RACT 13 LAN

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