SpiroScout

Basic Information

• Brand Name: SpiroScout
• Primary DI: 04250972300103
• Version / Model: 04421
• Catalog Number: 04421
• Company Name: Ganshorn Medizin Electronic GmbH
• Labeler DUNS: 318498177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-07
• Public Version: 6
• Public Version Date: 2022-03-08
• Public Version Status: Update
• Public Device Record Key: e575a874-bd0d-436b-b8f9-e02be037b989

Device Description

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZG	Spirometer, Diagnostic	Anesthesiology	868.1840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250972300103	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160116	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 60 – 105 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity