AccessGUDID - DEVICE: Sensonics' Microencapsulated Smell Tests (G051BSIT9)

GUDID

Device Identifier (DI) Information

Brand Name: Sensonics' Microencapsulated Smell Tests
Version or Model: BSIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sensonics, Inc.

Primary DI Number: G051BSIT9
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107213563 *Terms of Use

Device Description: The B-SIT is a brief 12-item self-administered microencapsulated odorant test for evaluating olfactory function. It is contained in a single booklet, unlike the 4-booklet UPSIT, and is applicable in any industrial, clinical, or survey setting where a rapid, yet reliable, assessment of olfactory function is required. As with the case of the UPSIT, the odorants are embedded in 10-50 µm urea-formaldehyde polymer micro-capsules fixed in a proprietary binder and positioned on scent strips at the bottom of the pages of the test booklet. The stimuli are released by scratching the strips with a pencil tip in a standardized manner. Above each odorant strip is a multiple-choice question with four alternative responses. For example, one of the items reads: “This odor smells most like: a) motor oil; b) garlic; c) rose; or d) lemon. The subject is required to mark one of the four alternatives even if no smell sensation is perceived (i.e., the test is forced-choice).

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:	Yes
Prescription Use (Rx):	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRK	Kit, Test, Olfactory

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: cbff3b76-7515-46cf-aa94-c84c77885c67
Public Version Date: February 06, 2025
Public Version Number: 1
DI Record Publish Date: January 29, 2025