Sensonics' Waterless Taste Test Strips

Basic Information

• Brand Name: Sensonics' Waterless Taste Test Strips
• Primary DI: G051WETT0
• Version / Model: WETT
• Company Name: Sensonics, Inc.
• Labeler DUNS: 107213563
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-29
• Public Version: 1
• Public Version Date: 2025-02-06
• Public Version Status: New
• Public Device Record Key: 720abfc1-5bd2-42f5-98bc-025c65a86a42

Device Description

The Waterless Empirical Taste Test (WETT®) was developed to provide scientists, clinicians, and medical professionals with a standardized, easy-to-use, and reliable method for determining taste function. The WETT® test is comprised of a series of disposable plastic strips whose tips are made of monomer cellulose embedded with either sucrose (sweet), citric acid (sour), sodium chloride (salty), caffeine (bitter), monosodium glutamate (umami), or blank tastants. The sweet, sour, salty, bitter, and umami tastants appear in four concentrations [sucrose: 0.20, 0.10, 0.05, 0.025 g/ml; citric acid: 0.20, 0.10, 0.05, 0.025 g/ml; sodium chloride: 0.25, 0.125, 0.0625, 0.0313 g/ml; caffeine: 0.088, 0.044, 0.022, 0.011 g/ml; monosodium glutamate: 0.135, 0.068, 0.034, 0.017 g/ml]. Each concentration is presented to the examinee twice, in a counter-balanced order. Blank strips are interspersed throughout the test in a specific pattern designed to negate the need for any rinsing with water between tastes. The WETT® is comprised of an ergonomically designed kit that allows portability and efficient administration of the test. Three drawers with eight divided compartments contain each of the tastants in the order of presentation. Once all have been presented, the order is reversed. This order of presentation is confirmed on the testing sheets. Most testing can be done in 15 minutes or less. Detailed instructions are provided in an accompanying manual to minimize variability in test administration.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NNJ	Gustometer, Non-Sterile	Ear, Nose, Throat	874.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65155	Gustatory test stick	A non-powered, flavoured device intended to be used to assess a patient’s gustatory function (sense of taste). It typically consists of a flavoured stick(s) intended to be placed on the tongue of the patient, followed by patient description of taste perception. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G051WETT0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]