16760

GUDID 05415067045676

Pectoral Charging Apparel

ST. JUDE MEDICAL, INC.

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• Primary Device ID: 05415067045676
• NIH Device Record Key: 07b3ae60-87d8-4b44-927b-b83c678e4135
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 16760
• Catalog Number: 16760
• 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: 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
• 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°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°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°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°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°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°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°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°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°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°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°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°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°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°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°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°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°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°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°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067045676 [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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