ScoutTube

Primary DI
04250972300202
Brand
ScoutTube
Company
Ganshorn Medizin Electronic GmbH
Model
019420620
Catalog number
019420620
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.
Published
2021-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYPMouthpiece, Breathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250972300202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250972300202042509723002024250972300202

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+491726288283quality@ganshorn.de

Regulatory Flags#

DUNS number
318498177
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07613365500301PowerCube+ SeriesA2024-12-20
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07613365500431PowerCube+ SeriesA2024-12-20
07613365501018PowerCube+ SeriesA2024-12-20
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07613365501070PowerCube+ SeriesA2024-12-20
07613365501094PowerCube+ SeriesA2024-12-20
07613365500011SpiroScoutF0134005012023-07-03
07613365500035SpiroScout SP PlusD0134005632023-07-03
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