AccessGUDID - DEVICE: Simply Tranquil II (00089518000498)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00089518000498
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131229197 *Terms of Use

Device Description: The Simply Tranquil II utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing in the canal design. Designed for Tinnitus assistance.

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?
43826	Air-conduction tinnitus masker, in-the-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 sound generator, contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)], that delivers the noise to the eardrum through air. The microphone in some types may measure the level of the background noise and adjust accordingly the masking signal. The digital design of the device 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: dfafbb18-f40e-4320-981a-ba90fd1fbdda
Public Version Date: August 05, 2022
Public Version Number: 4
DI Record Publish Date: September 28, 2016