Access® Therapy

GUDID 00613994397836

PROG 7436 KINETRA EZ PATNT ROHs US MKT

MEDTRONIC, INC.

Active-implantable-device communicator
Primary Device ID00613994397836
NIH Device Record Keyedbc68d1-7f74-4937-a256-d03eff8b411f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess® Therapy
Version Model Number7436
Company DUNS796986144
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
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

Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994397836 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MFRStimulator, brain, implanted, for behavior modification

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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Trademark Results [Access]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCESS
ACCESS
98849021 not registered Live/Pending
Access Members, Inc.
2024-11-12
ACCESS
ACCESS
98604507 not registered Live/Pending
Better Earth LLC
2024-06-17
ACCESS
ACCESS
98301775 not registered Live/Pending
Access Group, Inc.
2023-12-06
ACCESS
ACCESS
98289355 not registered Live/Pending
Penumbra, Inc.
2023-11-28
ACCESS
ACCESS
98182378 not registered Live/Pending
Troy and Sabina Benavides
2023-09-15
ACCESS
ACCESS
98017184 not registered Live/Pending
Sony Interactive Entertainment Inc.
2023-05-28
ACCESS
ACCESS
97936930 not registered Live/Pending
Winnebago Industries, Inc.
2023-05-15
ACCESS
ACCESS
97792738 not registered Live/Pending
Piv Train Inc
2023-02-13
ACCESS
ACCESS
97756255 not registered Live/Pending
Coppel S.A. de C.V.
2023-01-16
ACCESS
ACCESS
97202119 not registered Live/Pending
Access Alternative Investments, Inc.
2022-01-04
ACCESS
ACCESS
97180047 not registered Live/Pending
Wicket, LLC
2021-12-20
ACCESS
ACCESS
90827919 not registered Live/Pending
Access Eforms, LP
2021-07-14

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