GUDID 00643169713161

CRTG 304-03POR PORCINE HMS TAN 5L 9PK

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic
Primary Device ID00643169713161
NIH Device Record Key6dd6c8e8-3cc5-431e-8004-d0a464a8eed1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number304-03POR
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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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169713161 [Unit of Use]
GS120643169713165 [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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