Simply Tranquil I

GUDID 00089518000474

The Simply Tranquil I utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing in the canal design. Designed for patients that suffer from Tinnitus

GENERAL HEARING INSTRUMENT, INC.

In-the-ear air-conduction tinnitus masker, digital

• Primary Device ID: 00089518000474
• NIH Device Record Key: 4b8bcd7a-7d66-405e-b785-ed340344d667
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simply Tranquil I
• Version Model Number: Simply Tranquil I,10A,Digital,Pair
• 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	00089518000474 [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 [Simply Tranquil I]

• 00089518000474: The Simply Tranquil I utilizes advanced digital signal processing with broadband white noise int
• 00089518000467: The Simply Tranquil I utilizes advanced digital signal processing with broadband white noise int
• 00089518000450: The Simply Tranquil I utilizes advanced digital signal processing with broadband white noise int