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 | 04057155000719 | 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 | |
9 | 04057155000603 | 2.x | Accessory to ERT's Asthma Monitor device for professional users | BZG | Spirometer, Diagnostic | 2 | Asthma Monitor AMOS app | |
10 | 04057155000542 | SpiroSphere Standard | Diagnostic spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | SpiroSphere | |
11 | 04057155000535 | SpiroSphere | Diagnostic spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | SpiroSphere | |
12 | 04057155000528 | SpiroSphere CT | Diagnostic spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | SpiroSphere | |
13 | 04057155000375 | SpiroSphere Sensor | Spirometer sensor unit to measure inspiratory and expiratory pulmonary function | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | SpiroSphere | |
14 | 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 | |
15 | 04057155000320 | Rotationsflowgeber Set | Set of three rotary flow sensors for single-patient use, accessory to Asthma Monitor | BZG | Spirometer, Diagnostic | 2 | Rotationsflowgeber Set | |
16 | 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 | |
17 | 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 | |
18 | 04057155000207 | AM3 G+ | Asthma Monitor, electronic peak flow meter with TCP/IP | BZG | Spirometer, Diagnostic | 2 | Asthma Monitor AM3 | |
19 | 04057155000191 | AM3 | Asthma Monitor, electronic peak flow meter | BZG | Spirometer, Diagnostic | 2 | Asthma Monitor AM3 | |
20 | 04057155000054 | MasterScope ECG | diagnostic device for ECG measurement and data collection | DPS | Electrocardiograph | 2 | MasterScope ECG | |
21 | 04057155000139 | FlowScreen | diagnostic spirometer for recording and assessing pulmonary function | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | FlowScreen | |
22 | 04057155000122 | FlowScreen CT | diagnostic spirometer for recording and assessing pulmonary function | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | FlowScreen | |
23 | 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 | |
24 | 04057155000634 | MasterScope WSSU | diagnostic spirometer for measurement and data collection of lung function parameters | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | MasterScope | |
25 | 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 | |
26 | 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 | |
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 | 04250892905693 | V-378540 | V-378540 | Vyntus BODY | Vyaire | VYAIRE MEDICAL GMBH |
2 | 04250892905679 | 706570 | 706570 | Isolation - Transformer | Vyaire | VYAIRE MEDICAL GMBH |
3 | 04250892905662 | 706572 | 706572 | Isolation - Transformer | Vyaire | VYAIRE MEDICAL GMBH |
4 | 04250892905228 | V-175428 | V-175428 | MasterScreen Body | MasterScreen | VYAIRE MEDICAL GMBH |
5 | 04250892905211 | V-175422 | V-175422 | MasterScreen Body/Diff | MasterScreen | VYAIRE MEDICAL GMBH |
6 | 04250892904955 | V-707254-13 | V-707254-13 | Vyntus SPIRO | Vyaire | VYAIRE MEDICAL GMBH |
7 | 04250892904931 | V-707254 | V-707254 | Vyntus SPIRO | Vyaire | VYAIRE MEDICAL GMBH |
8 | 04250892904689 | V-178500-13 | V-178500-13 | Vyntus BODY | Vyaire | VYAIRE MEDICAL GMBH |
9 | 04250892904672 | V-178500 | V-178500 | Vyntus BODY | Vyaire | VYAIRE MEDICAL GMBH |
10 | 04250892901688 | V-707254-13 | V-707254-13 | Vyntus SPIRO | Jaeger | VYAIRE MEDICAL GMBH |
11 | 04250892900841 | V-707254 | V-707254 | Vyntus Spiro | Jaeger | VYAIRE MEDICAL GMBH |
12 | 04057155000764 | SpiroSphere Standard | Diagnostic spirometer for measurement and data collection of lung function parameters | SpiroSphere | ERESEARCHTECHNOLOGY GMBH | |
13 | 04057155000757 | SpiroSphere | Diagnostic spirometer for measurement and data collection of lung function parameters | SpiroSphere | ERESEARCHTECHNOLOGY GMBH | |
14 | 04057155000726 | SpiroSphere CT | Diagnostic spirometer for measurement and data collection of lung function parameters | SpiroSphere | ERESEARCHTECHNOLOGY GMBH | |
15 | 04057155000719 | 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 | SpiroSphere | ERESEARCHTECHNOLOGY GMBH | |
16 | 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 | MasterScope | ERESEARCHTECHNOLOGY GMBH | |
17 | 04057155000634 | MasterScope WSSU | diagnostic spirometer for measurement and data collection of lung function parameters | MasterScope | ERESEARCHTECHNOLOGY GMBH | |
18 | 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 | MasterScope | ERESEARCHTECHNOLOGY GMBH | |
19 | 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 | MasterScope | ERESEARCHTECHNOLOGY GMBH | |
20 | 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 | MasterScope | ERESEARCHTECHNOLOGY GMBH | |
21 | 04057155000542 | SpiroSphere Standard | Diagnostic spirometer for measurement and data collection of lung function parameters | SpiroSphere | ERESEARCHTECHNOLOGY GMBH | |
22 | 04057155000535 | SpiroSphere | Diagnostic spirometer for measurement and data collection of lung function parameters | SpiroSphere | ERESEARCHTECHNOLOGY GMBH | |
23 | 04057155000528 | SpiroSphere CT | Diagnostic spirometer for measurement and data collection of lung function parameters | SpiroSphere | ERESEARCHTECHNOLOGY GMBH | |
24 | 04057155000412 | ERT PT | Pneumotachograph tube, accessory, single-patient use | ERT PT | ERESEARCHTECHNOLOGY GMBH | |
25 | 04057155000382 | P-Rohr Set SpiroPro | Set of ten Pneumotachograph tubes, single-patient use, accessory to SpiroPro | P-Rohr Set SpiroPro | ERESEARCHTECHNOLOGY GMBH | |
26 | 04057155000375 | SpiroSphere Sensor | Spirometer sensor unit to measure inspiratory and expiratory pulmonary function | SpiroSphere | ERESEARCHTECHNOLOGY GMBH | |
27 | 04057155000368 | Pneumotach, white and grey | Pneumotachograph, accessory to spirometer handle | Pneumotach | ERESEARCHTECHNOLOGY GMBH | |
28 | 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 | SpiroSphere | ERESEARCHTECHNOLOGY GMBH | |
29 | 04057155000139 | FlowScreen | diagnostic spirometer for recording and assessing pulmonary function | FlowScreen | ERESEARCHTECHNOLOGY GMBH | |
30 | 04057155000122 | FlowScreen CT | diagnostic spirometer for recording and assessing pulmonary function | FlowScreen | ERESEARCHTECHNOLOGY GMBH | |
31 | 04057155000078 | Pneumotach, grey | Pneumotachograph, accessory to spirometer handle | Pneumotach | ERESEARCHTECHNOLOGY GMBH | |
32 | 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 | MasterScope | ERESEARCHTECHNOLOGY GMBH | |
33 | 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 | MasterScope | ERESEARCHTECHNOLOGY GMBH | |
34 | 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 | MasterScope | ERESEARCHTECHNOLOGY GMBH | |
35 | 04057155000016 | MasterScope | diagnostic Spirometer for measurement and data collection of lung function parameters | MasterScope | ERESEARCHTECHNOLOGY GMBH | |
36 | 00853452007024 | SpiroVision | SPIROVISION PC BASED SPIROMETER | FUTUREMED | FUTUREMED AMERICA, INC. | |
37 | B200HF012 | HF012 | Paramagnetic Shape analyzer Product 0012 | Shape | SHAPE MEDICAL SYSTEMS, INC. | |
38 | B200HF001 | HF001 | Shape-HF analyzer | Shape-HF | SHAPE MEDICAL SYSTEMS, INC. | |
39 | B2009012 | 0012-9012 | Full Shape II system with paramagnetic analyzer | Shape II System Refurbished | SHAPE MEDICAL SYSTEMS, INC. | |
40 | B20089001 | 0008-9001 | Shape-HF system | Shape-HF | SHAPE MEDICAL SYSTEMS, INC. | |
41 | B20083012 | 0008-3012 | Full Shape II system with paramagnetic analyzer | Shape Vital Sign System | SHAPE MEDICAL SYSTEMS, INC. | |
42 | B20044012 | 0004-4012 | Disposable patient interface with filter 0004-4012 | Disposable Patient Interface with filter | SHAPE MEDICAL SYSTEMS, INC. | |
43 | B20044001 | Disposable Patient Interface | Disposable Patient Interface is part of the Shape-HF testing system | Shape-HF | SHAPE MEDICAL SYSTEMS, INC. | |
44 | B20040011 | Shape | Shape DPI | Shape | SHAPE MEDICAL SYSTEMS, INC. | |
45 | 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 | |
46 | 34250892904925 | V-171466-13 | V-171466-13 | Vyntus SPIRO | Vyaire | VYAIRE MEDICAL GMBH |
47 | 34250892904918 | V-171466 | V-171466 | Vyntus SPIRO | Vyaire | VYAIRE MEDICAL GMBH |
48 | 34250892904901 | V-707293 | V-707293 | Vyntus SPIRO | Vyaire | VYAIRE MEDICAL GMBH |
49 | 34250892900835 | V-171466-13 | V-171466-13 | Vyntus Spiro | Jaeger | VYAIRE MEDICAL GMBH |
50 | 34250892900781 | V-171466 | V-171466 | Vyntus Spiro | Jaeger | VYAIRE MEDICAL GMBH |