Assert-IQ™ DM5500

GUDID 05415067047809

EL+ Insertable Cardiac Monitor

ST. JUDE MEDICAL, INC.

Implantable cardiac monitor

• Primary Device ID: 05415067047809
• NIH Device Record Key: 54645548-2faa-42b5-a5d9-ee7623ddae82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assert-IQ™
• Version Model Number: DM5500
• Catalog Number: DM5500
• 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: false
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight. Storage excursions permitted from 59°- 86° F (15°- 30°C).

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067047809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230286

FDA Product Code

• MXC: Recorder, event, implantable cardiac, (without arrhythmia detection)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

On-Brand Devices [Assert-IQ™]

• 05415067047816: 3+ Insertable Cardiac Monitor
• 05415067047809: EL+ Insertable Cardiac Monitor
• 05415067047793: 3 Insertable Cardiac Monitor