GUDID 20613994923329

CONTROL 306-05POR PORC HMS ORANGE 10BX

MEDTRONIC, INC.

Coagulation timer IVD
Primary Device ID20613994923329
NIH Device Record Key0191ac89-b683-4be0-a625-f47f4f080f2d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number306-05POR
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count10
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

Special Storage Condition, SpecifyBetween 0 and 0 *Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C).
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C).
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994923325 [Unit of Use]
GS120613994923329 [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 Date2016-06-18

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