SpiroScout SP - The SpiroScout SP is a PC based system designed - Ganshorn Medizin Electronic GmbH

Duns Number:318498177

Device Description: The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro rec 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

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More Product Details

Catalog Number

013400562

Brand Name

SpiroScout SP

Version/Model Number

A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Device Record Status

Public Device Record Key

5fbbca51-93b8-4531-afba-20b3fa048b12

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

November 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GANSHORN MEDIZIN ELECTRONIC GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 3