PACEART® SYSTEM ECG MODULE

GUDID 00613994546180

ECG P127TUV PACEART SYSTEM FW 1.09 GLBL

MEDTRONIC, INC.

Patient health record information system application software
Primary Device ID00613994546180
NIH Device Record Key8ffcc8e3-82d9-48fe-81ac-2b5e55cb55d7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePACEART® SYSTEM ECG MODULE
Version Model NumberP127TUV
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

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994546180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-04
Device Publish Date2019-10-25

Devices Manufactured by MEDTRONIC, INC.

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Trademark Results [PACEART]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PACEART
PACEART
87252084 5195774 Live/Registered
Medtronic, Inc.
2016-11-30
PACEART
PACEART
74074454 1650680 Live/Registered
Paceart, Inc.
1990-07-02

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