Sensonics' Microencapsulated Smell Tests

Basic Information

• Brand Name: Sensonics' Microencapsulated Smell Tests
• Primary DI: G051PSIT9
• Version / Model: PSIT
• 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: 68d30eed-2372-4f61-85d3-b871d8047fe9

Device Description

The Pocket Smell Tests provide a quick 3-, 4-, 6-, or 8-odor forced-choice screening test using the same microencapsulated odorant technology as the Smell Identification Test. It is a very brief screen for gross olfactory dysfunction. If the test subject misses one or more of the test items, then the 40-item Smell Identification Test™ should be given to accurately quantify the degree of smell loss.

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
NRK	Kit, Test, Olfactory	Ear, Nose, Throat	874.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65154	Olfactory test stick	A non-powered, scented device intended to be used to assess a patient’s olfactory function (normosmia, hyposmia, or anosmia). It typically consists of a scented stick(s) intended to be sniffed by the patient, followed by patient description of smell 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	G051PSIT9	HIBCC

Customer Contacts

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