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.

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20199150000320 - NA2025-03-14 CUSTOM PACK BB10V15R5 5PK SUPP
20199150000344 - NA2025-03-14 CUSTOM PACK BB8S27R1 5PK Y LINE CB
20199150000368 - NA2025-03-14 CUSTOM PACK BB11P52R1 5PK Y LINE CB
00199150000616 - NA2025-03-14 CUSTOM PACK BB11N74R15 CCS-ST MARKS
00199150000623 - NA2025-03-14 CUSTOM PACK BB7E57R18 PUMP
00199150000630 - NA2025-03-14 CUSTOM PACK BB11B96R4 HEART PACK

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

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