GUDID 10673978522484

SPIKE BT945 TRANSFER

MEDTRONIC, INC.

Blood-processing autotransfusion system set Blood-processing autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set
Primary Device ID10673978522484
NIH Device Record Keyd3af32af-c60d-4b5a-9940-0c0b768a39c6
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBT945
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
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
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS100673978522487 [Primary]
GS110673978522484 [Package]
Contains: 00673978522487
Package: PK [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWETUBING, PUMP, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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