GUDID 20643169713264

CARTRIDGE 402-07 HR HTC BXD 11L 20BX

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic
Primary Device ID20643169713264
NIH Device Record Key3584dbd6-ca9a-48d5-8fad-ba854ec8d992
Commercial Distribution StatusIn Commercial Distribution
Version Model Number402-07
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count20
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 *The HR HTC should be stored in a stable environment, either at
Special Storage Condition, SpecifyBetween 0 and 0 *The HR HTC should be stored in a stable environment, either at

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169713260 [Unit of Use]
GS120643169713264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JBPACTIVATED WHOLE BLOOD CLOTTING TIME

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 Date2016-09-25

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