Infinity™ 6661

GUDID 05415067020253

Implantable Pulse Generator

ST. JUDE MEDICAL, INC.

Deep brain electrical stimulation system

• Primary Device ID: 05415067020253
• NIH Device Record Key: d6e9ba7e-3704-4f67-b1a8-f555c5bc808a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity™
• Version Model Number: 5
• Catalog Number: 6661
• 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: true
• Lot Batch: true
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to liquids

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067020253 [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: true

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