No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04057155000573 | Mouthpiece, 30 pieces | Mouthpiece, V-892894 repackaged for Clinical Trial use | BYP | Mouthpiece, Breathing | 1 | Vyaire | |
2 | 04057155000382 | P-Rohr Set SpiroPro | Set of ten Pneumotachograph tubes, single-patient use, accessory to SpiroPro | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | P-Rohr Set SpiroPro | |
3 | 04057155000368 | Pneumotach, white and grey | Pneumotachograph, accessory to spirometer handle | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | Pneumotach | |
4 | 04057155000078 | Pneumotach, grey | Pneumotachograph, accessory to spirometer handle | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | Pneumotach | |
5 | 04057155000764 | SpiroSphere Standard | Diagnostic spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | SpiroSphere | |
6 | 04057155000757 | SpiroSphere | Diagnostic spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | SpiroSphere | |
7 | 04057155000726 | SpiroSphere CT | Diagnostic spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | SpiroSphere | |
8 | 04057155000603 | 2.x | Accessory to ERT's Asthma Monitor device for professional users | BZG | Spirometer, Diagnostic | 2 | Asthma Monitor AMOS app | |
9 | 04057155000542 | SpiroSphere Standard | Diagnostic spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | SpiroSphere | |
10 | 04057155000535 | SpiroSphere | Diagnostic spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | SpiroSphere | |
11 | 04057155000528 | SpiroSphere CT | Diagnostic spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | SpiroSphere | |
12 | 04057155000375 | SpiroSphere Sensor | Spirometer sensor unit to measure inspiratory and expiratory pulmonary function | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | SpiroSphere | |
13 | 04057155000351 | SpiroSphere Main Unit | Main Unit of diagnostic spirometer for measurement and data collection of lung f Main Unit of diagnostic spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | SpiroSphere | |
14 | 04057155000320 | Rotationsflowgeber Set | Set of three rotary flow sensors for single-patient use, accessory to Asthma Monitor | BZG | Spirometer, Diagnostic | 2 | Rotationsflowgeber Set | |
15 | 04057155000313 | Clean Peak Flow Meter - Children | The Clean Peak Flow Meter is an invasive, non-electrical medical device for moni The Clean Peak Flow Meter is an invasive, non-electrical medical device for monitoring respiratory conditions. The device is for measuring the Peak Expiratory Flow (PEF) or the maximum velocity of air expelled from the lungs. The children model is intended for patients from 6 years on up to 12 years. | BZH | Meter, Peak Flow, Spirometry | 2 | Clean Peak Flow Meter | |
16 | 04057155000306 | Clean Peak Flow Meter - Adults | The Clean Peak Flow Meter is an invasive, non-electrical medical device for moni The Clean Peak Flow Meter is an invasive, non-electrical medical device for monitoring respiratory conditions. The device is for measuring the Peak Expiratory Flow (PEF) or the maximum velocity of air expelled from the lungs. | BZH | Meter, Peak Flow, Spirometry | 2 | Clean Peak Flow Meter | |
17 | 04057155000207 | AM3 G+ | Asthma Monitor, electronic peak flow meter with TCP/IP | BZG | Spirometer, Diagnostic | 2 | Asthma Monitor AM3 | |
18 | 04057155000191 | AM3 | Asthma Monitor, electronic peak flow meter | BZG | Spirometer, Diagnostic | 2 | Asthma Monitor AM3 | |
19 | 04057155000054 | MasterScope ECG | diagnostic device for ECG measurement and data collection | DPS | Electrocardiograph | 2 | MasterScope ECG | |
20 | 04057155000139 | FlowScreen | diagnostic spirometer for recording and assessing pulmonary function | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | FlowScreen | |
21 | 04057155000122 | FlowScreen CT | diagnostic spirometer for recording and assessing pulmonary function | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | FlowScreen | |
22 | 04057155000641 | MasterScope WSSU with ECG | diagnostic spirometer for measurement and data collection of lung function param diagnostic spirometer for measurement and data collection of lung function parameters with option ECG | BTY,DPS | Calculator, Predicted Values, Pulmonary Function,Electrocardiograph | 2 | MasterScope | |
23 | 04057155000634 | MasterScope WSSU | diagnostic spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | MasterScope | |
24 | 04057155000627 | MasterScope CT with ECG | diagnostic spirometer for measurement and data collection of lung function param diagnostic spirometer for measurement and data collection of lung function parameters with option ECG | DPS,BTY | Electrocardiograph,Calculator, Predicted Values, Pulmonary Function | 2 | MasterScope | |
25 | 04057155000610 | MasterScope CT | diagnostic spirometer for measurement and data collection of lung function param diagnostic spirometer for measurement and data collection of lung function parameters in Clinical Trials | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | MasterScope | |
26 | 04057155000566 | WSSU | Spirometer sensor to measure inspiratory and expiratory pulmonary function for c Spirometer sensor to measure inspiratory and expiratory pulmonary function for connection to software | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | MasterScope | |
27 | 04057155000177 | AM1+ | Asthma Monitor, electronic peak flow meter | BZG | Spirometer, Diagnostic | 2 | Asthma Monitor AM1+ | |
28 | 04057155000061 | Digital Handle USB | Spirometer handle to measure inspiratory and expiratory pulmonary function; part Spirometer handle to measure inspiratory and expiratory pulmonary function; part of MasterScope and MasterScope CT | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | MasterScope | |
29 | 04057155000030 | MasterScope CT with ECG | diagnostic spirometer for measurement and data collection of lung function param diagnostic spirometer for measurement and data collection of lung function parameters with option ECG | DPS,BTY | Electrocardiograph,Calculator, Predicted Values, Pulmonary Function | 2 | MasterScope | |
30 | 04057155000023 | MasterScope CT | diagnostic spirometer for measurement and data collection of lung function param diagnostic spirometer for measurement and data collection of lung function parameters in Clinical Trials | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | MasterScope | |
31 | 04057155000016 | MasterScope | diagnostic Spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | MasterScope | |
32 | 04057155000412 | ERT PT | Pneumotachograph tube, accessory, single-patient use | BTY | Calculator, Predicted Values, Pulmonary Function | ERT PT | ||
33 | 04057155000337 | Rotationsflowgeber | Rotary flow sensor for single-patient use, accessory to Asthma Monitor | BZG | Spirometer, Diagnostic | 2 | Rotationsflowgeber |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00853452007024 | SpiroVision | SPIROVISION PC BASED SPIROMETER | FUTUREMED | FUTUREMED AMERICA, INC. | |
2 | B200HF012 | HF012 | Paramagnetic Shape analyzer Product 0012 | Shape | SHAPE MEDICAL SYSTEMS, INC. | |
3 | B200HF001 | HF001 | Shape-HF analyzer | Shape-HF | SHAPE MEDICAL SYSTEMS, INC. | |
4 | B2009012 | 0012-9012 | Full Shape II system with paramagnetic analyzer | Shape II System Refurbished | SHAPE MEDICAL SYSTEMS, INC. | |
5 | B20089001 | 0008-9001 | Shape-HF system | Shape-HF | SHAPE MEDICAL SYSTEMS, INC. | |
6 | B20083012 | 0008-3012 | Full Shape II system with paramagnetic analyzer | Shape Vital Sign System | SHAPE MEDICAL SYSTEMS, INC. | |
7 | B20044012 | 0004-4012 | Disposable patient interface with filter 0004-4012 | Disposable Patient Interface with filter | SHAPE MEDICAL SYSTEMS, INC. | |
8 | B20044001 | Disposable Patient Interface | Disposable Patient Interface is part of the Shape-HF testing system | Shape-HF | SHAPE MEDICAL SYSTEMS, INC. | |
9 | B20040011 | Shape | Shape DPI | Shape | SHAPE MEDICAL SYSTEMS, INC. | |
10 | 74250179233555 | MetaLyzer3B | The CORTEX CPET systems are intended for use in CPET, Spirometric, and Basal-/Re The CORTEX CPET systems are intended for use in CPET, Spirometric, and Basal-/Resting Metabolic Rate Tests for the purpose to objectify the ventilatory, cardio-circulatory and metabolic capacity. With the following indications, they support the user in finding or confirming diagnoses, determining therapy programs and monitoring therapies.In a CPET test, a patient undergoes a period of defined physical stress (normally 10-20 minutes). Hereby data is measured about ventilation, gas exchange and heart rate. On basis of these measured data, further data is calculated and displayed, in order to depict the performance of the cardio-respiratory system.In a spirometry test, the patient performs defined breathing maneuvers (VC, FVC, MVV). Thereby measurement data of the respiratory strength and volume is collected and displayed, in order to show the mechanical capacity of the respiratory system.In a Basal-/Resting Metabolic Rate Test the patient performs a rest test (normally 15-20 minutes). Thereby measurement data of the gas exchange is collected and displayed, in order to estimate the Basal-/Resting Metabolic Rate. | CORTEX CPET System | CORTEX BIOPHYSIK GMBH | |
11 | 34250892904925 | V-171466-13 | V-171466-13 | Vyntus SPIRO | Vyaire | VYAIRE MEDICAL GMBH |
12 | 34250892904918 | V-171466 | V-171466 | Vyntus SPIRO | Vyaire | VYAIRE MEDICAL GMBH |
13 | 34250892904901 | V-707293 | V-707293 | Vyntus SPIRO | Vyaire | VYAIRE MEDICAL GMBH |
14 | 34250892900835 | V-171466-13 | V-171466-13 | Vyntus Spiro | Jaeger | VYAIRE MEDICAL GMBH |
15 | 34250892900781 | V-171466 | V-171466 | Vyntus Spiro | Jaeger | VYAIRE MEDICAL GMBH |
16 | 34250892900583 | V-707293 | V-707293 | Vyntus Spiro | Jaeger | VYAIRE MEDICAL GMBH |
17 | 18052400180539 | Q-NRG+ | COSMED | C O S M E D SRL | ||
18 | 18052400180522 | Q-NRG | COSMED | C O S M E D SRL | ||
19 | 18052400180379 | Pony FX MIP/MEP | The COSMED Pony FX pulmonary function testing system is a standalone and modular The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and pulse oximetry. | COSMED | C O S M E D SRL | |
20 | 18052400180355 | Q-Box | The COSMED Quark Series system Is a modular system with multiple configurations, The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions. | COSMED | C O S M E D SRL | |
21 | 18052400180188 | Quark CPET | The COSMED Quark Series system Is a modular system with multiple configurations, The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions. | COSMED | C O S M E D SRL | |
22 | 18052400180171 | Quark RMR | The COSMED Quark Series system Is a modular system with multiple configurations, The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions. | COSMED | C O S M E D SRL | |
23 | 18052400180164 | Quark PFT | The COSMED Quark Series system Is a modular system with multiple configurations, The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions. | COSMED | C O S M E D SRL | |
24 | 18052400180065 | Quark SPIRO | The COSMED Quark Series system Is a modular system with multiple configurations, The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions. | COSMED | C O S M E D SRL | |
25 | 18052400180058 | Pony FX Flowsafe | The COSMED Pony FX pulmonary function testing system is a standalone and modular The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and pulse oximetry. | COSMED | C O S M E D SRL | |
26 | 18052400180041 | Pony FX | The COSMED Pony FX pulmonary function testing system is a standalone and modular The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and pulse oximetry. | COSMED | C O S M E D SRL | |
27 | 18052400180034 | microQuark | The COSMED microQuark pulmonary function testing system is a modular laboratory The COSMED microQuark pulmonary function testing system is a modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation). | COSMED | C O S M E D SRL | |
28 | 14250892905799 | V-707759 | V-707759 | Vyntus BODY accessories set | Vyaire | VYAIRE MEDICAL GMBH |
29 | 14250892903917 | V-707389 | V-707389 | FPV block | Vyaire | VYAIRE MEDICAL GMBH |
30 | 14250892903900 | V-707388 | V-707388 | FPV shutter mechanism | Vyaire | VYAIRE MEDICAL GMBH |
31 | 14250892903726 | V-707392 | V-707392 | FPV housing clamp | Vyaire | VYAIRE MEDICAL GMBH |
32 | 14250892903566 | 709554 | 709554 | Pneumotach plastic PT 36, not heatable | Vyaire | VYAIRE MEDICAL GMBH |
33 | 14250892902064 | 709554 | 709554 | Pneumotach plastic PT 36, not heatable | Jaeger | VYAIRE MEDICAL GMBH |
34 | 10846446033045 | 776278 | 776278 | SNIP & MAX PRESSURE OPTION ENCORE | Vmax | CAREFUSION CORPORATION |
35 | 10846446032987 | 30119-001 | 30119-001 | SWR KIT VMAX ENCORE VER 28-5 SERIES | Vmax | CAREFUSION CORPORATION |
36 | 10846446032949 | 28701-001 | 28701-001 | VMAX READING STATION UPGRADE | Vmax | CAREFUSION CORPORATION |
37 | 10846446032925 | 28528-001 | 28528-001 | VMAX SOFTWARE UPGRADE | Vmax | CAREFUSION CORPORATION |
38 | 10846446032840 | 27678-001 | 27678-001 | KIT,SWR VMAX ENCORE 21-2D | Vmax | CAREFUSION CORPORATION |
39 | 10846446032833 | 27671-001 | 27671-001 | KIT SWR VMAX ENCORE 27-3D | Vmax | CAREFUSION CORPORATION |
40 | 10846446032826 | 27566-001 | 27566-001 | SINGLE MONITOR CONSOLE | Vmax | CAREFUSION CORPORATION |
41 | 10846446032819 | 27565-001 | 27565-001 | DUAL HORIZONTAL MONITOR CONSOLE | Vmax | CAREFUSION CORPORATION |
42 | 10846446032802 | 27564-001 | 27564-001 | DUAL STACKED MONITOR CONSOLE | Vmax | CAREFUSION CORPORATION |
43 | 10846446032734 | 23796-001 | 23796-001 | CD,VMAX VER 28 | Vmax | CAREFUSION CORPORATION |
44 | 10846446032703 | 12253 | 12253 | KIT,DUAL ARM DUAL MONITOR,OPTIPLEX XE | Vmax | CAREFUSION CORPORATION |
45 | 10846446032697 | 777409-101-RFB | 777409-101-RFB | VMAX ENCORE 29C,REFURB | Vmax | CAREFUSION CORPORATION |
46 | 10846446032680 | 777407-101-RFB | 777407-101-RFB | VMAX ENCORE 29,REFURB | Vmax | CAREFUSION CORPORATION |
47 | 10846446032673 | 777405-101-RFB | 777405-101-RFB | VMAX ENCORE 22D,REFURB | Vmax | CAREFUSION CORPORATION |
48 | 10846446032666 | 777401-101-RFB | 777401-101-RFB | VMAX ENCORE 229D,REFURB | Vmax | CAREFUSION CORPORATION |
49 | 10846446032659 | 777400-101-RFB | 777400-101-RFB | VMAX ENCORE 229,REFURB | Vmax | CAREFUSION CORPORATION |
50 | 10846446032642 | 777503 | 777503 | VMAX ENCORE 20C UNIT ASSEMBLY | Vmax | CAREFUSION CORPORATION |