Identity
- Trade Name
- ScoutTube FDA UDI
- Generic Name
- Breathing mouthpiece, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 019420620 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 019420620 FDA UDI
- Primary DI / UDI-DI
- 04250972300202 FDA UDI
- FDA Product Code
- BYP FDA UDI
- GMDN Term
- Breathing mouthpiece, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breathing mouthpiece, single-use
ScoutTube by Ganshorn Medizin Electronic GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ganshorn Medizin Electronic GmbH
Sources (1)
- FDA UDI 72fb4381-d28d-4c87-a5e7-c955c7eb2fd1 36 fields · synced May 29, 2026