Tranquil II OTE

GUDID 00089518000436

The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus

GENERAL HEARING INSTRUMENT, INC.

Behind-the-ear air-conduction tinnitus masker

• Primary Device ID: 00089518000436
• NIH Device Record Key: 2bbc277c-8f0f-4d59-a45c-eef706a8272d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tranquil II OTE
• Version Model Number: Tranquil II,OTE,10A,Digital,Grey,Right
• Company DUNS: 131229197
• Company Name: GENERAL HEARING INSTRUMENT, 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: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00089518000436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061459

FDA Product Code

• KLW: Masker, Tinnitus

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: 2016-09-28

On-Brand Devices [Tranquil II OTE]

• 00089518000443: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi
• 00089518000436: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi
• 00089518000429: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi
• 00089518000412: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi
• 00089518000405: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi
• 00089518000399: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi
• 00089518000382: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi
• 00089518000375: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi
• 00089518000368: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi
• 00089518000351: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi
• 00089518000344: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi
• 00089518000337: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noi