55600

GUDID 05415067034960

Clinician Programmer App

ST. JUDE MEDICAL, INC.

Multiple active implantable device programmer

• Primary Device ID: 05415067034960
• NIH Device Record Key: 70178e01-06b7-47d1-9b0e-a3895e653864
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 55600
• Catalog Number: 55600
• Company DUNS: 149818952
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067034960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010032

FDA Product Code

• LGW: Stimulator, spinal-cord, totally implanted for pain relief
• MHY: Stimulator, electrical, implanted, for parkinsonian tremor

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: 2023-01-12
• Device Publish Date: 2023-01-04

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