GUDID 00673978170114

MOTOR R95120-03 EXT DRIVE RECOND 540T

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump drive unit
Primary Device ID00673978170114
NIH Device Record Keycfa56806-6f31-4af8-b103-050699214247
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberR95120-03
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100673978170114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWAControl, pump speed, cardiopulmonary bypass

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 Date2015-06-19

Devices Manufactured by MEDTRONIC, INC.

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