AccessGUDID - DEVICE: Tranquil I OTE (00089518000276)

GUDID

Device Identifier (DI) Information

Brand Name: Tranquil I OTE
Version or Model: Tranquil I,OTE,10A,Digital,Black,Left
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENERAL HEARING INSTRUMENT, INC.

Primary DI Number: 00089518000276
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131229197 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Behind-the-ear air-conduction tinnitus masker	A battery-powered digital acoustic device designed to provide noise of sufficient intensity and bandwidth to mask (make less noticeable and provide temporary relief from) tinnitus (a ringing sound in the ear or internal head noises). It typically consists of a miniature generator/microphone, contained in a case worn behind-the-ear (BTE), that delivers the noise to the eardrum through air; its digital design allows for the introduction of new tinnitus-masking software programs.

GMDN Preferred Term Name

GMDN Definition

Behind-the-ear air-conduction tinnitus masker

A battery-powered digital acoustic device designed to provide noise of sufficient intensity and bandwidth to mask (make less noticeable and provide temporary relief from) tinnitus (a ringing sound in the ear or internal head noises). It typically consists of a miniature generator/microphone, contained in a case worn behind-the-ear (BTE), that delivers the noise to the eardrum through air; its digital design allows for the introduction of new tinnitus-masking software programs.

FDA Product Code

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Product Code	Product Code Name
KLW	Masker, Tinnitus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061459	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3926e6b8-fcf4-4704-a6be-cb431f830170
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 28, 2016