ScoutTube

Basic Information

• Brand Name: ScoutTube
• Primary DI: 04250972300202
• Version / Model: 019420620
• Catalog Number: 019420620
• Company Name: Ganshorn Medizin Electronic GmbH
• Labeler DUNS: 318498177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-30
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 72fb4381-d28d-4c87-a5e7-c955c7eb2fd1

Device 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.

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYP	Mouthpiece, Breathing	Anesthesiology	868.5620	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44545	Breathing mouthpiece, single-use	A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250972300202	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius