CardioSight™ Reader

GUDID 00643169312098

MON 2020A2 CARDIOSIGHT 60601 3ED USA

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use
Primary Device ID00643169312098
NIH Device Record Key65e36b89-39ee-4583-b42f-2897b0b0bec8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioSight™ Reader
Version Model Number2020A2
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

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169312098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVZPulse generator, permanent, implantable

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 Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

00763000004101 - NA2025-09-02 COMMUNICATOR TM90T0 TDD PROX
00199150042050 - NA2025-09-01 CUSTOM PACK SSHY12R43R HLN BB8G55R1
00199150042104 - NA2025-09-01 CUSTOM PACK BB12R13R1 HLN SUTT PED
00199150042111 - NA2025-09-01 CUSTOM PACK BB12Q88R1 HLN INF SUTTE
00763000998271 - Affera™ Integrated Mapping System2025-09-01 MAP SYS AFR-00016 IMPEDANCE US PLX
00199150042005 - NA2025-08-29 CUSTOM PACK BB7E29R28 EVL 3/8
00199150042012 - NA2025-08-29 CUSTOM PACK BB11L88R8 EVL SUPPRT SM
00199150042029 - NA2025-08-29 CUSTOM PACK BB12P62R3 EVL 1/4

Trademark Results [CardioSight]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARDIOSIGHT
CARDIOSIGHT
78843441 3255486 Live/Registered
Medtronic, Inc.
2006-03-22
CARDIOSIGHT
CARDIOSIGHT
78470161 3069373 Live/Registered
Medtronic, Inc.
2004-08-19

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