DEVICE: Tranquil II OTE (00089518000368)

Device Identifier (DI) Information

Tranquil II OTE
Tranquil II,OTE,10A,Digital,Brown,Left
In Commercial Distribution

GENERAL HEARING INSTRUMENT, INC.
00089518000368
GS1

1
131229197 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
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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.
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FDA Product Code

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Product Code Product Code Name
KLW Masker, Tinnitus
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FDA Premarket Submission

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

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1601ba9e-0815-4d7f-aecc-94d605a3ff5c
July 06, 2018
3
September 28, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Customer Contact

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1-800-824-3021
customercare@generalhearing.com
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