gammaCore Sapphire 13016-04501-C

GUDID 00815203022045

gammaCore Sapphire 31-Day Refill Card Only

electroCore, Inc.

Migraine-therapy peripheral nerve electrical stimulator

• Primary Device ID: 00815203022045
• NIH Device Record Key: 317ae1b9-99d1-4c6b-af10-3a8d6766f01b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gammaCore Sapphire
• Version Model Number: 13016-04501-C
• Catalog Number: 13016-04501-C
• Company DUNS: 831341628
• Company Name: electroCore, 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815203022045 [Primary]

FDA Product Code

• QAK: Non-Invasive Vagus Nerve Stimulator For Migraine Headache

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: 2026-02-24
• Device Publish Date: 2026-02-16

On-Brand Devices [gammaCore Sapphire ]

• 00815203022687: gammaCore Sapphire Charging Station / Storage Case (Replacement with alternate power adapter)
• 00815203022236: gammaCore Sapphire EVAL
• 00815203022076: gammaCore Sapphire 12 Month Refill Card Only
• 00815203022052: gammaCore Sapphire 93 Day Refill Card Only
• 00815203022045: gammaCore Sapphire 31-Day Refill Card Only
• 00815203021864: gammaCore Sapphire Charging Station / Storage Case - Replacement
• 00815203020089: gammaCore Sapphire SLC Handset, Replacement