Confirm Rx™ DM3500

GUDID 05415067027320

Insertable Cardiac Monitor

ST. JUDE MEDICAL, INC.

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• Primary Device ID: 05415067027320
• NIH Device Record Key: ce568a40-e6bc-4a4d-b579-c273e9ab4102
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Confirm Rx™
• Version Model Number: DM3500
• Catalog Number: DM3500
• Company DUNS: 790268031
• 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: 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a clean area.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a clean area.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a clean area.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a clean area.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a clean area.
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067027320 [Primary]

FDA Product Code

• DSI: DETECTOR AND ALARM, ARRHYTHMIA

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-09
• Device Publish Date: 2017-11-13

On-Brand Devices [Confirm Rx™]

• 05415067027320: Insertable Cardiac Monitor
• 05415067034304: Implantable Cardiac Monitor Accessories