SJM MRI Activator™ EX4001

GUDID 05414734510059

Handheld Device

ST. JUDE MEDICAL, INC.

Implantable cardiac monitor programmer/transmitter/alarm 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: 05414734510059
• NIH Device Record Key: 42fc0676-6f78-4e21-b382-d7a4297b8a08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SJM MRI Activator™
• Version Model Number: EX4001
• Catalog Number: EX4001
• Company DUNS: 790268031
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734510059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140033

FDA Product Code

• LWP: Implantable pulse generator, pacemaker (non-CRT)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2017-11-03

On-Brand Devices [SJM MRI Activator™]

• 05414734510059: Handheld Device
• 05414734503648: Handheld Device