| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | M776CHRCO100 | G3 | CHR-CO-100 | The Pulmonx® Chartis System is designed to measure pressure and flow in order to The Pulmonx® Chartis System is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Console has a touch-screen user interface that is easy to navigate, and a mouse or keyboard is not required. Patient assessment data can be exported to a USB flash memory device. | BZG | Spirometer, Diagnostic | 2 | Chartis Console |
| 2 | 00811907031222 | EDC-TS-5.5-DM | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) selfexpanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it throughthe working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Delivery Catheter | |
| 3 | 00811907030720 | EDC-TS-5.5 | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Delivery Catheter | |
| 4 | 00811907030621 | EDC-TS-4.0-J | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Delivery Catheter | |
| 5 | 00811907030522 | EDC-TS-4.0 | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Delivery Catheter | |
| 6 | 00811907031819 | LIA-01-001 | The Lung Image Analysis (LIA) software is designed to aid in the interpretation The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional.The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format. | JAK | System, X-Ray, Tomography, Computed | 2 | Lung Image Analysis | |
| 7 | 00811907030423 | EBV-TS-5.5-LP | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it throughthe working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Endobronchial Valve | |
| 8 | 00811907030324 | EBV-TS-5.5 | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Endobronchial Valve | |
| 9 | 00811907030225 | EBV-TS-4.0-LP | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Endobronchial Valve | |
| 10 | 00811907030126 | EBV-TS-4.0 | The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. | NJK | Valve, Pulmonary | 3 | Zephyr Endobronchial Valve | |
| 11 | 00811907031123 | CHR-CO-300 | The Chartis Tablet Console is a two-part spirometry system comprised of a touchs The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. The balloon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time. | BZG | Spirometer, Diagnostic | 2 | Pulmonx Chartis Tablet Console | |
| 12 | M776CHRCA120 | G3 | CHR-CA-12.0 | The Chartis Catheter is a single use, sterile, disposable device designed to be The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure. The Chartis Catheter is a hollow catheter shaft made of medical-grade PEBAX. The Chartis Catheter is 169 cm in length with a working length of 72 cm and a 2.7 mm outer diameter. The distal end of the catheter employs an inflatable balloon made from a compliant elastomeric material. The catheter has two lumens: the main lumen allows air flow from the isolated lung compartment to the Console, and the second smaller lumen allows balloon inflation. The proximal end of the catheter has two ports, a balloon inflation port to inflate the distal balloon, and an obturator port with a luer fitting for connection to the Chartis Console via the Connector Set. A custom obturator inserted into the main lumen of the catheter is used for both pushability and to clear mucus that may obstruct the lumen during catheter manipulation in the airways. The only portion of the device that comes into bodily contact is the distal tip of the catheter, which is made from medical grade PEBAX (shaft) and a compliant elastomeric material (balloon). No medicinal substances are eluted from the catheter. | CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 2 | Chartis Catheter |
| 13 | 00811907030928 | G3 | CHR-CA-12.0 | The Chartis Catheter is a single use, sterile, disposable device designed to be The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure. The Chartis Catheter is a hollow catheter shaft made of medical-grade PEBAX. The Chartis Catheter is 169 cm in length with a working length of 72 cm and a 2.7 mm outer diameter. The distal end of the catheter employs an inflatable balloon made from a compliant elastomeric material. The catheter has two lumens: the main lumen allows air flow from the isolated lung compartment to the Console, and the second smaller lumen allows balloon inflation. The proximal end of the catheter has two ports, a balloon inflation port to inflate the distal balloon, and an obturator port with a luer fitting for connection to the Chartis Console via the Connector Set. A custom obturator inserted into the main lumen of the catheter is used for both pushability and to clear mucus that may obstruct the lumen during catheter manipulation in the airways. The only portion of the device that comes into bodily contact is the distal tip of the catheter, which is made from medical grade PEBAX (shaft) and a compliant elastomeric material (balloon). No medicinal substances are eluted from the catheter. | CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 2 | Chartis Catheter |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 06420099001094 | M9488-PCD | M915-PCD, PCD Spirometer Kit | MEDIKRO OY | ||
| 2 | 06420099000851 | M9492 | M914, Medikro® Primo | MEDIKRO OY | ||
| 3 | 06420099000837 | M9488 | M915, Medikro® Pro | MEDIKRO OY | ||
| 4 | 06420099000820 | M9487 | M913, Medikro® Nano | MEDIKRO OY | ||
| 5 | 05713867000193 | INN00500-1c | Innocor cardio-pulmonary function test equipment | Innocor | INNOVISION APS | |
| 6 | 05713867000186 | INN00500-1a | Innocor cardio-pulmonary function test equipment | Innocor | INNOVISION APS | |
| 7 | 05713867000179 | INN00400-1c | Innocor cardio-pulmonary function test equipment | Innocor | INNOVISION APS | |
| 8 | 05713867000162 | INN00400-1b | Innocor cardio-pulmonary function test equipment | Innocor | INNOVISION APS | |
| 9 | 05713867000155 | INN00400-1a | Innocor cardio-pulmonary function test equipment | Innocor | INNOVISION APS | |
| 10 | 05713867000100 | INN00010-1 | Innocor Cardio-pulmonary function test equipment | Innocor | INNOVISION APS | |
| 11 | 05713867000063 | INN00500 | Cardio-pulmonary function test & analysis equipment | Innocor | INNOVISION APS | |
| 12 | 05713867000056 | INN00400 | Cardio-pulmonary function test & analysis equipment | Innocor | INNOVISION APS | |
| 13 | 05713867000001 | INN00010 | Innocor Cardio-pulmonary function test equipment | Innocor | INNOVISION APS | |
| 14 | 05407003163018 | SpiroAir DLCO-He IB | SP-00-02 | Rolling seal Spirometer, intended for measuring lung volumes by spirometry and H Rolling seal Spirometer, intended for measuring lung volumes by spirometry and Helium dilution | SpiroAir | MEDI SOFT SA |
| 15 | 05099169794016 | 2120 | 2120 HAND HELD IN2ITIVE US & VITALOGRAPH REPORTS (1) | In2itive | VITALOGRAPH (IRELAND) LIMITED | |
| 16 | 05099169793019 | 2120 | 2120 HAND HELD IN2ITIVE US & PRINT CRADLE (1) | In2itive | VITALOGRAPH (IRELAND) LIMITED | |
| 17 | 05099169790018 | 2120 | CASE 2120 HAND HELD VITALOGRAPH IN2ITIVE US (1) | In2itive | VITALOGRAPH (IRELAND) LIMITED | |
| 18 | 05099169777330 | 6800 | MODEL 6800 INTRAC(1) | Pneumotrac | VITALOGRAPH (IRELAND) LIMITED | |
| 19 | 05099169777019 | 6800 | MODEL 6800 PNEUMOTRAC US(1) | Pneumotrac | VITALOGRAPH (IRELAND) LIMITED | |
| 20 | 05099169770010 | 6800 | 6800 PNEUMOTRAC USA | Pneumotrac | VITALOGRAPH (IRELAND) LIMITED | |
| 21 | 05099169414846 | 6600 | GENERIC CLINICAL TRIAL CASE - MIP MEP COMPACT(1) | Compact | VITALOGRAPH (IRELAND) LIMITED | |
| 22 | 05034480309143 | PF30S | PF30S | Pulmonary Function Filter for pulmonary function testing | Pall® Pro-Tec Filter for Pulmonary Function Testing | PALL INTERNATIONAL SÀRL |
| 23 | 05030267161553 | 1691009 | PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE AND NOSECLIP | PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE AND NOSECLIP | INTERSURGICAL INCORPORATED | |
| 24 | 05030267161010 | 1691004 | PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE | PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE | INTERSURGICAL INCORPORATED | |
| 25 | 05030267160631 | 1691005 | PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE | PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE | INTERSURGICAL INCORPORATED | |
| 26 | 05030267160587 | 1691006 | PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE | PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE | INTERSURGICAL INCORPORATED | |
| 27 | 05030267160563 | 1691007 | PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE | PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE | INTERSURGICAL INCORPORATED | |
| 28 | 05030267160440 | 1691016 | PULMO-PROTECT, PULMONARY FUNCTION FILTER, MOUTHPIECE, NOSE CLIP | PULMO-PROTECT, PULMONARY FUNCTION FILTER, MOUTHPIECE, NOSE CLIP | INTERSURGICAL INCORPORATED | |
| 29 | 05030267160402 | 1691053 | PULMO-PROTECT™ LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP | PULMO-PROTECT™ LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP | INTERSURGICAL INCORPORATED | |
| 30 | 05030267156054 | 1691003 | PULMO-PROTECT LUNG FUNCTION FILTER | PULMO-PROTECT LUNG FUNCTION FILTER | INTERSURGICAL INCORPORATED | |
| 31 | 05030267146499 | 1691013 | PULMO-PROTECT BREATHING FILTER WITH FLEXIBLE MOUTHPIECE AND NOSE CLIP | PULMO-PROTECT BREATHING FILTER WITH FLEXIBLE MOUTHPIECE AND NOSE CLIP | INTERSURGICAL INCORPORATED | |
| 32 | 05030267146437 | 1691014 | PULMO-PROTECT BREATHING FILTER WITH FLEXIBLE MOUTHPIECE AND NOSE CLIP | PULMO-PROTECT BREATHING FILTER WITH FLEXIBLE MOUTHPIECE AND NOSE CLIP | INTERSURGICAL INCORPORATED | |
| 33 | 05030267136087 | 1691010 | PULMO-PROTECT LUNG FUNCTION FILTER WITH FLEXIBLE MOUTHPIECE AND NOSE CLIP | PULMO-PROTECT LUNG FUNCTION FILTER WITH FLEXIBLE MOUTHPIECE AND NOSE CLIP | INTERSURGICAL INCORPORATED | |
| 34 | 05030267136032 | 1691002 | PULMO-PROTECT LUNG FUNCTION FILTER | PULMO-PROTECT LUNG FUNCTION FILTER | INTERSURGICAL INCORPORATED | |
| 35 | 05030267135981 | 1691001 | PULMO-PROTECT LUNG FUNCTION FILTER | PULMO-PROTECT LUNG FUNCTION FILTER | INTERSURGICAL INCORPORATED | |
| 36 | 05030267135813 | 1691051 | PULMO-PROTECT LUNG FUNCTION FILTER | PULMO-PROTECT LUNG FUNCTION FILTER | INTERSURGICAL INCORPORATED | |
| 37 | 05030267135790 | 1691050 | PULMO-PROTECT LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP | PULMO-PROTECT LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP | INTERSURGICAL INCORPORATED | |
| 38 | 05030267135776 | 1691012 | PULMO-PROTECT™ LUNG FUNCTION FILTER, FLEXIBLE MOUTHPIECE AND NOSE CLIP | PULMO-PROTECT™ LUNG FUNCTION FILTER, FLEXIBLE MOUTHPIECE AND NOSE CLIP | INTERSURGICAL INCORPORATED | |
| 39 | 05030267135752 | 1691011 | PULMO-PROTECT LUNG FUNCTION FILTER | PULMO-PROTECT LUNG FUNCTION FILTER | INTERSURGICAL INCORPORATED | |
| 40 | 05030267135721 | 1691000 | PULMO-PROTECT LUNG FUNCTION FILTER | PULMO-PROTECT LUNG FUNCTION FILTER | INTERSURGICAL INCORPORATED | |
| 41 | 05030267135707 | 1691052 | PULMO-PROTECT LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP | PULMO-PROTECT LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP | INTERSURGICAL INCORPORATED | |
| 42 | 04260176127796 | CCS-200 Spirometer | Benson | MAICO DIAGNOSTICS GMBH | ||
| 43 | 04260176127772 | CCS-200 Spirometer | Benson | MAICO DIAGNOSTICS GMBH | ||
| 44 | 04250972300172 | Rev.D | 013400563 | The SpiroScout SP plus is intended exclusively for use with the following SCHILL The SpiroScout SP plus is intended exclusively for use with the following SCHILLER devices. CARDIOVIT CS-104 SPIROVIT SP-1 G2 CARDIOVIT AT-102 G2The SpiroScout SP plus is an ultrasonic measuring system which is used for pulmonary function diagnostics. It determines the transit times of the ultrasonic signals and can be used with the above-mentioned Schiller devices to measure and analyse respiratory flow and volume. | SpiroScout SP plus | GANSHORN MEDIZIN ELECTRONIC GMBH |
| 45 | 04250972300134 | A | 013400562 | The SpiroScout SP is a PC based system designed to measure and record FVC and SV 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 | SpiroScout SP | GANSHORN MEDIZIN ELECTRONIC GMBH |
| 46 | 04250972300103 | 04421 | 04421 | The SpiroScout is a PC based system designed to measure and record FVC and SV Sp The SpiroScout 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. The SpiroScout is available with the following Options. Tidal Breath Analysis for paediatrics Rhinomanometrie Capnovolumetry (evaluation off additional parameters during tidal breathing, see software Ganshorn.LFX) HL7/ network (network connection via software Ganshorn.LFX) | SpiroScout | GANSHORN MEDIZIN ELECTRONIC GMBH |
| 47 | 04250892980249 | 2.5 | 36-SWR1134 | Spirometry PC Software | Micro Medical | CAREFUSION U.K. 232 LIMITED |
| 48 | 04250892904597 | 5.7 | V-770868-13 | JLAB Software | Vyaire | VYAIRE MEDICAL GMBH |
| 49 | 04250892904580 | 5.7 | V-770808 | JLAB Software | Vyaire | VYAIRE MEDICAL GMBH |
| 50 | 04250892904153 | 2.5 | 36-SWR1134 | Spirometry PC Software | Vyaire | VYAIRE MEDICAL GMBH |