Sniffin' Sticks - Extended Test

Basic Information

• Brand Name: Sniffin' Sticks - Extended Test
• Primary DI: 04260676240124
• Version / Model: LA-13-00435
• Catalog Number: LA-13-00435
• Company Name: Burghart Messtechnik GmbH
• Labeler DUNS: 341406604
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-10
• Public Version: 2
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: ae9d3d4a-3b56-48f9-9c81-a92380cf6633

Device Description

The Extended Test (also called “TDI-Test“ – Threshold, Discrimination, Identification) consists of 3 individual tests. A threshold test, a discrimination test and an identi-fication test. Each of these tests generates a number of points, which is added up to the TDI score at the end. The user is given a diagnostic classification of the patient's ability to smell. This is done by evaluating the number of points achieved. For the score, also called TDI score, there are standard values, which were determined by a validation study. The maximum number of points is 48, which is divided between the 3 tests.

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	04260676240124	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight