Azure™ S SR MRI SureScan™

GUDID 00643169634640

IPG W3SR01 AZURE S SR MRI WL USA

MEDTRONIC, INC.

Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive
Primary Device ID00643169634640
NIH Device Record Keybe1ab7bd-06cc-46e0-840f-da24393db385
Commercial Distribution StatusIn Commercial Distribution
Brand NameAzure™ S SR MRI SureScan™
Version Model NumberW3SR01
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
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 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169634640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWPImplantable pulse generator, pacemaker (non-CRT)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-24
Device Publish Date2017-12-02

On-Brand Devices [Azure™ S SR MRI SureScan™]

00643169871977IPG W3SR01 AZURE S SR MRI WL USA BCP
00643169634640IPG W3SR01 AZURE S SR MRI WL USA
00763000316716IPG W3SR01 AZURE S SR MRI USA

Trademark Results [Azure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AZURE
AZURE
98422516 not registered Live/Pending
PESCAINDE PRIVATE LIMITED
2024-02-27
AZURE
AZURE
98283654 not registered Live/Pending
Zhejiang Opalus Industry And Trade Co.,LTD
2023-11-24
AZURE
AZURE
98187250 not registered Live/Pending
Azure Products
2023-09-19
AZURE
AZURE
98041978 not registered Live/Pending
Bentley Motors Limited
2023-06-14
AZURE
AZURE
97886421 not registered Live/Pending
Biomet 3i, LLC
2023-04-13
AZURE
AZURE
97495078 not registered Live/Pending
Microsoft Corporation
2022-07-08
AZURE
AZURE
97177870 not registered Live/Pending
Tilevera LLC
2021-12-17
AZURE
AZURE
90709396 not registered Live/Pending
Aspen Surgical Products, Inc.
2021-05-13
AZURE
AZURE
90663537 not registered Live/Pending
Biomet 3i, LLC
2021-04-22
AZURE
AZURE
90635592 not registered Live/Pending
Laurendeau, Cameron
2021-04-09
AZURE
AZURE
90531989 not registered Live/Pending
ZOM Holding, LP
2021-02-17
AZURE
AZURE
90337276 not registered Live/Pending
West Coast Pita & Foods, Inc.
2020-11-23

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