NeuroPace® Remote Monitor Kit

GUDID 00855547005199

The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, 1 Telephone Cord and 1 Telephone Line Splitter.

Neuropace, Inc.

Brain-responsive electrical stimulation system

• Primary Device ID: 00855547005199
• NIH Device Record Key: 7e9a4d63-82e0-4b6f-a46c-778be553b0c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroPace® Remote Monitor Kit
• Version Model Number: DTR-300-K
• Company DUNS: 123369238
• Company Name: Neuropace, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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(866)726-3876
• Email: customerservice@neuropace.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855547005083 [Primary]
GS1	00855547005199 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100026

FDA Product Code

• PFN: Implanted brain stimulator for epilepsy

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: 2014-09-24

On-Brand Devices [NeuroPace® Remote Monitor Kit]

• 00855547005243: The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, 1
• 00855547005182: The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case an
• 00855547005199: The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, 1
• 00855547005434: The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, and 1 Carrying Cas