femSense Kinderwunsch

GUDID 09120095900014

SteadySense GmbH

Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser
Primary Device ID09120095900014
NIH Device Record Keyaf0fffda-cf05-44e6-8f32-3926de408497
Commercial Distribution StatusIn Commercial Distribution
Brand NamefemSense Kinderwunsch
Version Model Number1
Company DUNS300492871
Company NameSteadySense 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

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109120095900014 [Primary]

FDA Product Code

LHDDevice, Fertility Diagnostic, Proceptive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-25
Device Publish Date2021-05-17

Devices Manufactured by SteadySense GmbH

09120095900274 - femSense Ovulation Tracker2022-11-03
09120095900021 - femSense Fertility2021-07-23
09120095900014 - femSense Kinderwunsch2021-05-25
09120095900014 - femSense Kinderwunsch2021-05-25

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