Infinity™ 6884

GUDID 05415067023988

Patient Manual and Magnet

ST. JUDE MEDICAL, INC.

Deep brain electrical stimulation system

• Primary Device ID: 05415067023988
• NIH Device Record Key: c0f255b8-174e-4038-8e06-0bf8af5845ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity™
• Version Model Number: 6884
• Catalog Number: 6884
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067023988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140009

FDA Product Code

• MHY: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-30

On-Brand Devices [Infinity™]

• 05415067030023: Implantable Pulse Generator
• 05415067030016: Implantable Pulse Generator
• 05415067023988: Patient Manual and Magnet
• 05415067020277: Implantable Pulse Generator
• 05415067020253: Implantable Pulse Generator
• 05415067020246: Implantable Pulse Generator