AccessGUDID - DEVICE: Tranquil II OTE (00089518000337)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00089518000337
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131229197 *Terms of Use

Device Description: 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

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43018	Air-conduction tinnitus masker, out-of-ear	A battery-powered digital acoustic device designed to provide noise of sufficient intensity and bandwidth to mask tinnitus (a ringing sound in the ear or internal head noises) by neutralizing a patient’s perception of the symptoms for temporary relief. It typically consists of a miniature generator/microphone or speaker, which may be contained in a case worn behind-the-ear (BTE) or worn on the body (e.g., on a neck pendant, clipped to clothing), that delivers white noise to the eardrum through air; its digital design allows for the introduction of new tinnitus-masking software programs.	Active	false

FDA Product Code

[?]

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

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ededcd31-bb3a-4cd2-955d-ead1c03609a4
Public Version Date: August 05, 2022
Public Version Number: 4
DI Record Publish Date: September 28, 2016