ClearUP Sinus Pain Relief SN101

GUDID 00850006251025

ClearUP Sinus Relief Device is a smaller package system

TIVIC HEALTH SYSTEMS INC.

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• Primary Device ID: 00850006251025
• NIH Device Record Key: 4ecfbad8-496e-4a34-a726-dda9da855304
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearUP Sinus Pain Relief
• Version Model Number: SN101
• Catalog Number: SN101
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850006251025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182025

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief
• QNU: Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion

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: 2020-08-24
• Device Publish Date: 2020-08-15

On-Brand Devices [ClearUP Sinus Pain Relief ]

• 00850006251025: ClearUP Sinus Relief Device is a smaller package system
• 00850006251032: ClearUP Sinus Relief Device 2.0
• 00850006251179: ClearUP Sinus Pain Relief 2.0