St. Jude Medical Infinity™ 6371

GUDID 05415067030344

8CH Flex Extn, 50 cm

ST. JUDE MEDICAL, INC.

Deep brain electrical stimulation system

• Primary Device ID: 05415067030344
• NIH Device Record Key: 71024140-66a7-4ce4-b730-b61ca2dcd80a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: St. Jude Medical Infinity™
• Version Model Number: DBS System
• Catalog Number: 6371
• Company DUNS: 149818952
• 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: 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 Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067030344 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-24
• Device Publish Date: 2018-08-23

On-Brand Devices [St. Jude Medical Infinity™]

• 05415067030351: 8CH Flex Extn, 60 cm
• 05415067030344: 8CH Flex Extn, 50 cm
• 05415067030337: 8CH Directional Lead, 40 cm, 1.5
• 05415067030320: 8CH Directional Lead, 40 cm, 0.5
• 05415067030313: 8CH Directional Lead, 30 cm, 1.5
• 05415067030306: 8CH Directional Lead, 30 cm, 0.5
• 05415067020864: 8CH Flex Extn, 90 cm
• 05415067020857: 8CH Flex Extn, 60 cm
• 05415067020703: 8CH Directional Lead, 40 cm, 1.5
• 05415067020697: 8CH Directional Lead, 40 cm, 1.5
• 05415067020680: 8CH Directional Lead, 40 cm, 0.5
• 05415067020673: 8CH Directional Lead, 40 cm, 0.5
• 05415067020666: 8CH Directional Lead, 30 cm, 1.5
• 05415067020659: 8CH Directional Lead, 30 cm, 1.5
• 05415067020642: 8CH Directional Lead, 30 cm, 0.5
• 05415067020635: 8CH Directional Lead, 30 cm, 0.5
• 05415067020307: 8CH Flex Extn, 50 cm