DEVICE: SpiroScout (04250972300103)
Device Identifier (DI) Information
SpiroScout
04421
In Commercial Distribution
04421
Ganshorn Medizin Electronic GmbH
04421
In Commercial Distribution
04421
Ganshorn Medizin Electronic GmbH
The SpiroScout 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.
The SpiroScout is available with the following Options.
Tidal Breath Analysis for paediatrics
Rhinomanometrie
Capnovolumetry (evaluation off additional parameters during tidal breathing, see software Ganshorn.LFX)
HL7/ network (network connection via software Ganshorn.LFX)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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13680 | Diagnostic spirometer, professional |
An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.
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FDA Product Code
[?]Product Code | Product Code Name |
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BZG | Spirometer, Diagnostic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K160116 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Atmospheric Pressure: between 60 and 105 KiloPascal |
Storage Environment Temperature: between -20 and 50 Degrees Celsius |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e575a874-bd0d-436b-b8f9-e02be037b989
March 08, 2022
6
February 07, 2017
March 08, 2022
6
February 07, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49977162220
quality@ganshorn.de
quality@ganshorn.de