GUDID 00643169713208

CRTG 304-07POR PORC HMS ORG 5L INT 9PK

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic
Primary Device ID00643169713208
NIH Device Record Key9a88307e-d52a-4d24-b1ca-c80dc3c0298b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number304-07POR
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count9
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
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

Device Dimensions

Device Size Text, specify0
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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated 2°C-10°C

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169713208 [Unit of Use]
GS120643169713202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOXANALYZER, HEPARIN, AUTOMATED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-17
Device Publish Date2023-04-08

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