Scentific Test Kit 02U111000

GUDID 07290019255109

The Scentific test device is used to determine whether an olfactory loss is present. The device includes scents that are presented to the patient's nose to subjectively assess the patient's ability to perceive scents.

APPSCENT MEDICAL LTD

Olfactory test stick
Primary Device ID07290019255109
NIH Device Record Keyc06cedbc-387d-4724-b868-56216b2f4b70
Commercial Distribution StatusIn Commercial Distribution
Brand NameScentific Test Kit
Version Model Number1
Catalog Number02U111000
Company DUNS532387650
Company NameAPPSCENT MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 77 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 77 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 77 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 77 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290019255109 [Primary]

FDA Product Code

NRKKit, Test, Olfactory

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-24
Device Publish Date2026-02-16

Devices Manufactured by APPSCENT MEDICAL LTD

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07290019255109 - Scentific Test Kit2026-02-24The Scentific test device is used to determine whether an olfactory loss is present. The device includes scents that are presented to the patient's nose to subjectively assess the patient's ability to perceive scents.
07290019255109 - Scentific Test Kit2026-02-24 The Scentific test device is used to determine whether an olfactory loss is present. The device includes scents that are present

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