GUDID 00763000108281

MOTOR 560A EXTERNAL DRIVE LONG PLX

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump drive unit
Primary Device ID00763000108281
NIH Device Record Key3613e2bc-393a-4a0e-a88d-908602d4afc1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number560A
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000108281 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-15
Device Publish Date2019-03-07

Devices Manufactured by MEDTRONIC, INC.

20763000980096 - NA2025-08-25 IMPEDANCE PATCH AFR-00015
20763000980119 - NA2025-08-25 MAGNETIC PATCH AFR-00021
00199150039371 - NA2025-08-22 CUSTOM PACK BB11U72R1 P/T
00199150040872 - NA2025-08-22 CUSTOM PACK BB4K95R22 HLO PERFNPLEG
00199150041145 - NA2025-08-22 CUSTOM PACK BB12Q87R1 HLN VAMC NASH
00199150041978 - NA2025-08-22 CUSTOM PACK BB10F40R2 ACCESORY
00199150041299 - NA2025-08-19 CUSTOM PACK BB8E60R12 EVL PED E
20199150041118 - NA2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.