Access® Therapy Controller

GUDID 00613994877277

PRGRMR 7436 PATIENT KINETRA EZ

MEDTRONIC, INC.

Active-implantable-device communicator Active-implantable-device communicator Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer

• Primary Device ID: 00613994877277
• NIH Device Record Key: 5a045483-ee34-442b-84f5-bc4e6d667efd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access® Therapy Controller
• Version Model Number: 7436
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *30-75% Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994877277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960009

FDA Product Code

• NHL: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [Access® Therapy Controller]

• 00613994926852: PRGMR 7436 PATIENT KINETRA
• 00613994877277: PRGRMR 7436 PATIENT KINETRA EZ