FDA.reportPublic FDA data

SpiroScout SP

Primary DI
04250972300134
Brand
SpiroScout SP
Company
Ganshorn Medizin Electronic GmbH
Model
A
Catalog number
013400562
Device description
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
Published
2021-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250972300134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250972300134042509723001344250972300134

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometerAn electrically-powered device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]. It is an instrument used in a clinical setting with a mouthpiece and tube attached to a computerized unit to process the data from patient ventilatory efforts, volume and/or flow sensors, a display, and usually a graph recorder. The data are compared to standardized values or the patient's former values to help identify or evaluate chronic pulmonary disorders such as asthma, emphysema, or bronchitis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure60 KiloPascal105 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49977162220quality@ganshorn.de

Regulatory Flags#

DUNS number
318498177
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613365500400PowerCube+ SeriesA2024-12-20
07613365501193PowerCube+ SeriesA2025-03-31
07613365501209PowerCube+ SeriesA2025-03-31
07613365501216PowerCube+ SeriesA2025-03-31
07613365501223PowerCube+ SeriesA2025-03-31
07613365501230PowerCube+ Series A2025-03-31
07613365501247PowerCube+ Series A2025-03-31
07613365501254PowerCube+ SeriesA2025-03-31
07613365500301PowerCube+ SeriesA2024-12-20
07613365500431PowerCube+ Series A2024-12-20
07613365501018PowerCube+ SeriesA2024-12-20
07613365501032PowerCube+ SeriesA2024-12-20
07613365501070PowerCube+ SeriesA2024-12-20
07613365501094PowerCube+ SeriesA2024-12-20
07613365500127SpiroDefA2024-12-20
07613365500141SpiroDefA2024-12-20
07613365500202SpiroDefA2024-12-20
07613365500110SpiroDefA2024-12-20
07613365500134SpiroDefA2024-12-20
07613365500196SpiroDefA2024-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZG2026-06-02
07640142190554EasyOne Sky SpirometerNDD Medizintechnik AGBZG2026-04-21
08052990320288MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320295MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
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08052990320462MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320479MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320509MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320516MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320547MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320554MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320561MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990322022MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
14250892909117JaegerJaeger Medical GmbHBZG2025-08-11
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07613365501209PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365501216PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365501223PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365501230PowerCube+ Series Ganshorn Medizin Electronic GmbHBZG2025-03-31
07613365501247PowerCube+ Series Ganshorn Medizin Electronic GmbHBZG2025-03-31
07613365501254PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2025-03-31
07613365500301PowerCube+ SeriesGanshorn Medizin Electronic GmbHBZG2024-12-20