Sensonics' Waterless Taste Test Strips

Basic Information

• Brand Name: Sensonics' Waterless Taste Test Strips
• Primary DI: G051WETTSA530
• Version / Model: WETT-SA53
• 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: c0e0959c-21bb-4b61-a905-31403d4c1b1c

Device Description

The Self-Administered Waterless Empirical Taste Test™ (WETT®-SA53) is an easy and inexpensive method for quantitatively evaluating taste function. Delivery of tastants is via plastic strips with proprietary pads of monomer cellulose that are embedded with either sucrose (sweet), citric acid (sour), sodium chloride (salty), caffeine (bitter), monosodium glutamate (umami), or blank tastants. No liquid rinsing is required. The test strips are located in four pouches or packs from which they can be individually removed for testing. The first pack contains strips numbered from 1 to 13, the second contains strips numbered 14 to 27, the third pack from 28 to 40, and fourth pack from 41 to 53.

Device Characteristics

• Single Use: Yes
• 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	G051WETTSA530	HIBCC

Customer Contacts

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