Axium™ MN10700

GUDID 05415067025593

Clinical Programmer Kit

ST. JUDE MEDICAL, INC.

Implantable spinal cord electrical stimulation system programmer

• Primary Device ID: 05415067025593
• NIH Device Record Key: 96d989b1-9f05-4f6f-934d-4e492505f520
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axium™
• Version Model Number: MN10700
• Catalog Number: MN10700
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067025593 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150004

FDA Product Code

• PMP: Dorsal root ganglion stimulator for pain relief

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: 2016-03-29

On-Brand Devices [Axium™]

• 05415067025661: Programmer Carrying Case For use with Patient Programmer MN10600-02
• 05415067025654: Programmer Carrying Case For use with Clinical Programmers
• 05415067025647: Programmer Charger Kit For use with Patient Programmer MN10600-02
• 05415067025630: Programmer Charger Kit For use with Clinical Programmer MN10700
• 05415067025623: Auxiliary Magnet
• 05415067025593: Clinical Programmer Kit
• 05415067025586: Patient Programmer Kit
• 05415067025579: 30cm Tunneling Tool Kit
• 05415067025500: Implantable Neurostimulator Kit
• 05415067025494: Trial Neurostimulator