16750

GUDID 05415067045652

Lumbar Charging Apparel

ST. JUDE MEDICAL, INC.

Noninvasive device battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger Implant battery charger

• Primary Device ID: 05415067045652
• NIH Device Record Key: 5a93d579-83ef-4559-ac31-4dd1094538e9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 16750
• Catalog Number: 16750
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067045652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010032

FDA Product Code

• LGW: Stimulator, spinal-cord, totally implanted for pain relief
• NHL: Stimulator, electrical, implanted, for parkinsonian symptoms

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

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