ClearUP Sinus Relief Pain SN100

GUDID 00850006251001

TIVIC HEALTH SYSTEMS INC.

Craniofacial analgesia electrical stimulator

• Primary Device ID: 00850006251001
• NIH Device Record Key: 68878fa3-6b2a-4f76-91b0-21d171a1001c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearUP Sinus Relief Pain
• Version Model Number: SN100
• Catalog Number: SN100
• Company DUNS: 080598314
• Company Name: TIVIC HEALTH 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850006251001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182025

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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: 2019-10-22
• Device Publish Date: 2019-10-14

Devices Manufactured by TIVIC HEALTH SYSTEMS INC.

• 00850006251179 - ClearUP Sinus Pain Relief: 2023-11-07 ClearUP Sinus Pain Relief 2.0
• 00850006251032 - ClearUP Sinus Pain Relief: 2023-10-26 ClearUP Sinus Relief Device 2.0
• 00850006251025 - ClearUP Sinus Pain Relief: 2020-08-24 ClearUP Sinus Relief Device is a smaller package system
• 00850006251001 - ClearUP Sinus Relief Pain: 2019-10-22
• 00850006251001 - ClearUP Sinus Relief Pain: 2019-10-22