Jot Dx™ DM4500

GUDID 05415067040046

Insertable Cardiac Monitor

ST. JUDE MEDICAL, INC.

Implantable cardiac monitor

• Primary Device ID: 05415067040046
• NIH Device Record Key: 3351cfde-cf55-4194-a762-c89b25d7cfb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jot Dx™
• Version Model Number: DM4500
• Catalog Number: DM4500
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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(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
• 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 Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions are permitted between 15°C and 30°C (59°F and 86°F).

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067040046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212206

FDA Product Code

• DSI: DETECTOR AND ALARM, ARRHYTHMIA

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-19
• Device Publish Date: 2021-07-09

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05415067043696 - Masters Series™: 2024-12-26 Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft
• 05415067044037 - Masters Series™: 2024-12-26 Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft
• 05415067044099 - Masters Series™: 2024-12-26 Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft
• 05415067049971 - AVEIR™: 2024-12-20 Patient Transmitter Software
• 05415067046468 - AVEIR™: 2024-12-19 Patient Transmitter Wired Electrodes
• 05415067046475 - AVEIR™: 2024-12-19 Patient Transmitter
• 05415067034809 - Merlin@home™: 2024-11-21 Transmitter
• 05414734504706 - Merlin@home™: 2024-11-12 Wireless Broadband Kit