66000

GUDID 05415067047670

Charger Kit, Pectoral

ADVANCED NEUROMODULATION SYSTEMS, INC.

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• Primary Device ID: 05415067047670
• NIH Device Record Key: 07e87429-a5f1-4653-93be-e40da430f010
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 66000
• Catalog Number: 66000
• Company DUNS: 021675699
• Company Name: ADVANCED NEUROMODULATION SYSTEMS, 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)
• Special Storage Condition, Specify: Between 0 and 0 *Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067047670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140009

FDA Product Code

• PJS: Stimulator, electrical, implanted, for essential tremor

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: 2024-02-26
• Device Publish Date: 2024-02-16

Devices Manufactured by ADVANCED NEUROMODULATION SYSTEMS, INC.

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• 05415067047670 - NA: 2024-02-26Charger Kit, Pectoral
• 05415067047670 - NA: 2024-02-26 Charger Kit, Pectoral
• 05414734402477 - SJM™: 2020-02-06
• 05414734402613 - Eon Mini™: 2020-02-06 Charging System Charger
• 05414734402620 - Eon Mini™: 2020-02-06
• 05414734405300 - Eon Mini LE™: 2020-02-06
• 05414734405324 - Eon Mini LE™: 2020-02-06
• 05415067023803 - SJM™: 2018-10-22 Clinician Programmer App