ScoutTube - The ScoutTube is a disposable breathing tube for - Ganshorn Medizin Electronic GmbH

Duns Number:318498177

Device Description: The ScoutTube is a disposable breathing tube for lung function measurement in measuring sy The ScoutTube is a disposable breathing tube for lung function measurement in measuring systems with ultrasound sensor.The ScoutTube is intended for use with the spirometers SpiroScout, SpiroScout SP and SpiroScout SP plus.Operating mode / Physical Principle:The ScoutTube is a disposable breathing tube for lung function measurement in measuring systems with ultrasound sensor, namely spirometers SpiroScout, SpiroScout SP and SpiroScout SP plus. The ScoutTube bundles and directs the air exhaled by the patient past the ultrasound sensor of the spirometer. The values determined in the process are sent to a software-supported diagnostic system for evaluation. A diagnosis can then be made by the specialist staff on the basis of the measurement results.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

019420620

Brand Name

ScoutTube

Version/Model Number

019420620

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

Yes

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

BYP

Product Code Name

Mouthpiece, Breathing

Device Record Status

Public Device Record Key

72fb4381-d28d-4c87-a5e7-c955c7eb2fd1

Public Version Date

December 08, 2021

Public Version Number

1

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