Merlin.net™ MN7000

GUDID 05415067047311

Merlin.net Software

ST. JUDE MEDICAL, INC.

Transtelephonic implantable pacemaker analysis system

• Primary Device ID: 05415067047311
• NIH Device Record Key: 4744a0b1-bb18-432b-a2bd-e117e655b278
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merlin.net™
• Version Model Number: MN7000
• Catalog Number: MN7000
• Company DUNS: 790268031
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067047311 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-16

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05415067050045 - Neutrino™: 2025-02-19 NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050052 - Gallant™: 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050076 - Neutrino™: 2025-02-19 NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050090 - Gallant™: 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050106 - Entrant™: 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050120 - Entrant™: 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067051844 - Agilis™ NxT Steerable Introducer Dual-Reach™: 2025-02-17 Steerable Introducer
• 05415067051851 - Agilis™ NxT Steerable Introducer Dual-Reach™: 2025-02-17 Steerable Introducer