GUDID 00673978166025

MOTOR 95120-005 BIOCONSOLE 3L 540T EDM

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump drive unit
Primary Device ID00673978166025
NIH Device Record Keyfa1c6aa4-08d7-4a7c-8e6a-aabf16ef7728
Commercial Distribution Discontinuation2017-11-30
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number95120-005
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 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 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100673978166025 [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 Date2015-06-18

Devices Manufactured by MEDTRONIC, INC.

20763000825380 - NA2024-11-20 CUSTOM PACK CB12B36R1 4PK DEL NIDO CPG
20763000984193 - NA2024-11-18 CUSTOM PACK BB12F71R5 4PK LOYOLA CPG
20763000982946 - NA2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD
00763000984007 - NA2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG
00763000984021 - NA2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE
00763000984151 - NA2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT
00763000984168 - NA2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS
00763000984175 - NA2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.