SJM MRI Activator™ EX4000

GUDID 05414734503648

Handheld Device

ST. JUDE MEDICAL, INC.

Implantable cardiac monitor programmer/transmitter/alarm

• Primary Device ID: 05414734503648
• NIH Device Record Key: 42f147c4-2a67-45f9-a5d0-8a5b65cc6c3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SJM MRI Activator™
• Version Model Number: EX4000
• Catalog Number: EX4000
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734503648 [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: 2017-02-07

On-Brand Devices [SJM MRI Activator™]

• 05414734510059: Handheld Device
• 05414734503648: Handheld Device