Sniffin' Sticks - Screening 12 LA-13-00436

GUDID 04260676240148

The Screening 12 test is intended to be used for examination of smell disorders on humans. The test results can be used to differentiate between Normosmia, Hyposmia and Anosmia, if the patient is cooperative.

Burghart Messtechnik GmbH

Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick
Primary Device ID04260676240148
NIH Device Record Key9f8a1a30-945a-4ae9-9656-7e46ac7adcdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSniffin' Sticks - Screening 12
Version Model NumberLA-13-00436
Catalog NumberLA-13-00436
Company DUNS341406604
Company NameBurghart Messtechnik GmbH
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de
Phone+494103800760
Emailinfo@burghart-mt.de

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS104260676240148 [Primary]

FDA Product Code

NRKKit, Test, Olfactory

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-04-21
Device Publish Date2020-11-10