SpiroScout SP 013400562

GUDID 07613365500042

The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. Spiroscout SP is technically identical to Spiroscout and is intended exclusively for use with Schiller's AT 102

Ganshorn Medizin Electronic GmbH

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Primary Device ID07613365500042
NIH Device Record Key4260c23d-3955-49fe-92dd-2b634eace32d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpiroScout SP
Version Model NumberA
Catalog Number013400562
Company DUNS318498177
Company NameGanshorn Medizin Electronic 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de
Phone+49977162220
Emailquality@ganshorn.de

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107613365500042 [Primary]

FDA Product Code

BZGSpirometer, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-11
Device Publish Date2023-07-03

On-Brand Devices [SpiroScout SP]

04250972300134The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro recording
07613365500042The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro recording

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