GUDID 20613994697244

CRTG 304-09POR PORC HMS WHT 5L INT 9PK

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic
Primary Device ID20613994697244
NIH Device Record Keyae7a3bde-3497-4817-8625-956d42f08706
Commercial Distribution StatusIn Commercial Distribution
Version Model Number304-09POR
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994697240 [Unit of Use]
GS120613994697244 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-13

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