| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 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. | BTY | Calculator, Predicted Values, Pulmonary Function | 2 | CORTEX CPET System |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10863604000312 | 3 | Satellite diagnostic spirometer | Satellite | JONES MEDICAL INSTRUMENT COMPANY | |
| 2 | 07290016675016 | MiniBox+ | The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting | MiniBox+ | PULMONE ADVANCED MEDICAL DEVICES LTD | |
| 3 | 07290016675009 | MiniBox | PUO-MiniBox | The MiniBox is intended to measure lung function in adult and pediatric patients The MiniBox is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes ). The MiniBox is to be used by either a physician, respiratory therapist, or technician. A cleared single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.The MiniBox measures all common spirometric measurements as well as relative and absolute lung volumes. | MiniBox | PULMONE ADVANCED MEDICAL DEVICES LTD |
| 4 | 05713867000193 | INN00500-1c | Innocor cardio-pulmonary function test equipment | Innocor | INNOVISION APS | |
| 5 | 05713867000186 | INN00500-1a | Innocor cardio-pulmonary function test equipment | Innocor | INNOVISION APS | |
| 6 | 05713867000179 | INN00400-1c | Innocor cardio-pulmonary function test equipment | Innocor | INNOVISION APS | |
| 7 | 05713867000162 | INN00400-1b | Innocor cardio-pulmonary function test equipment | Innocor | INNOVISION APS | |
| 8 | 05713867000155 | INN00400-1a | Innocor cardio-pulmonary function test equipment | Innocor | INNOVISION APS | |
| 9 | 05713867000063 | INN00500 | Cardio-pulmonary function test & analysis equipment | Innocor | INNOVISION APS | |
| 10 | 05713867000056 | INN00400 | Cardio-pulmonary function test & analysis equipment | Innocor | INNOVISION APS | |
| 11 | 05407003162011 | TransAir3 | 10-SA-03-TA | Pulmonary Function Testing Device, intended for measuring lung volumes by spirom Pulmonary Function Testing Device, intended for measuring lung volumes by spirometry and Helium dilution | TransAir3 | MEDI SOFT SA |
| 12 | 04250892905921 | V-707525 | V-707525 | MasterScreen Pneumo | Jaeger | VYAIRE MEDICAL GMBH |
| 13 | 04250892905914 | V-577400-13 | V-577400-13 | SentrySuite Server Software Win 10 | Vyaire | VYAIRE MEDICAL GMBH |
| 14 | 04250892905891 | 3.20 | V-770965 | SentrySuite Software | Vyaire | VYAIRE MEDICAL GMBH |
| 15 | 04250892905839 | v-178001-13 | v-178001-13 | Vyntus CPX | Vyaire | VYAIRE MEDICAL GMBH |
| 16 | 04250892905822 | 375119 | 375119 | APS Pro SA | Jaeger | VYAIRE MEDICAL GMBH |
| 17 | 04250892905808 | V-376406 | V-376406 | MasterScreen IOS | Jaeger | VYAIRE MEDICAL GMBH |
| 18 | 04250892905747 | V-707960 | V-707960 | Vyntus ONE | Vyaire | VYAIRE MEDICAL GMBH |
| 19 | 04250892905709 | 3.10 | V-770962-13 | SentrySuite Software | Vyaire | VYAIRE MEDICAL GMBH |
| 20 | 04250892905693 | V-378540 | V-378540 | Vyntus BODY | Vyaire | VYAIRE MEDICAL GMBH |
| 21 | 04250892905631 | V-176420 | V-176420 | MasterScreen IOS | Jaeger | VYAIRE MEDICAL GMBH |
| 22 | 04250892905600 | V-577084-13 | V-577084-13 | US Review Station SeS Win 10 | Vyaire | VYAIRE MEDICAL GMBH |
| 23 | 04250892905402 | 143250 | 143250 | Oxycon Mobile | Jaeger | VYAIRE MEDICAL GMBH |
| 24 | 04250892905389 | V-375170 | V-375170 | APS Pro SA | Jaeger | VYAIRE MEDICAL GMBH |
| 25 | 04250892905372 | V-375119-03 | V-375119-03 | APS Pro SA | Jaeger | VYAIRE MEDICAL GMBH |
| 26 | 04250892905365 | 375119-13 | 375119-13 | APS Pro SA | Jaeger | VYAIRE MEDICAL GMBH |
| 27 | 04250892905358 | 375111 | 375111 | APS Pro SA | Jaeger | VYAIRE MEDICAL GMBH |
| 28 | 04250892905341 | 706696 | 706696 | APS Pro SA | Jaeger | VYAIRE MEDICAL GMBH |
| 29 | 04250892905334 | V-171480-13 | V-171480-13 | MasterScreen Pneumo | Jaeger | VYAIRE MEDICAL GMBH |
| 30 | 04250892905327 | V-171470-13 | V-171470-13 | MasterScreen Pneumo | Jaeger | VYAIRE MEDICAL GMBH |
| 31 | 04250892905310 | V-171480 | V-171480 | MasterScreen Pneumo | Jaeger | VYAIRE MEDICAL GMBH |
| 32 | 04250892905303 | V-171470 | V-171470 | MasterScreen Pneumo | Jaeger | VYAIRE MEDICAL GMBH |
| 33 | 04250892905297 | V-171460 | V-171460 | MasterScreen Pneumo | Jaeger | VYAIRE MEDICAL GMBH |
| 34 | 04250892905280 | V-171420 | V-171420 | MasterScreen Pneumo | Jaeger | VYAIRE MEDICAL GMBH |
| 35 | 04250892905273 | V-171410 | V-171410 | MasterScreen Pneumo | Jaeger | VYAIRE MEDICAL GMBH |
| 36 | 04250892905266 | 171400 | 171400 | MasterScreen Pneumo | Jaeger | VYAIRE MEDICAL GMBH |
| 37 | 04250892905259 | V-176420-13 | V-176420-13 | MasterScreen IOS | Jaeger | VYAIRE MEDICAL GMBH |
| 38 | 04250892905242 | 176450-13 | 176450-13 | MasterScreen IOS | Jaeger | VYAIRE MEDICAL GMBH |
| 39 | 04250892905235 | 176400 | 176400 | MasterScreen IOS | Jaeger | VYAIRE MEDICAL GMBH |
| 40 | 04250892905204 | V-175423 | V-175423 | MasterScreen Body/Diff | Jaeger | VYAIRE MEDICAL GMBH |
| 41 | 04250892905198 | V-175425-13 | V-175425-13 | MasterScreen Body/Diff | Jaeger | VYAIRE MEDICAL GMBH |
| 42 | 04250892905181 | V-175423-13 | V-175423-13 | MasterScreen Body/Diff | Jaeger | VYAIRE MEDICAL GMBH |
| 43 | 04250892905174 | V-175420-13 | V-175420-13 | MasterScreen Body/Diff | Jaeger | VYAIRE MEDICAL GMBH |
| 44 | 04250892905167 | V-172401 | V-172401 | MasterScreen Body/Diff | Jaeger | VYAIRE MEDICAL GMBH |
| 45 | 04250892905150 | V-707340 | V-707340 | MasterScreen Body/Diff | Jaeger | VYAIRE MEDICAL GMBH |
| 46 | 04250892905143 | V-175420 | V-175420 | MasterScreen Body/Diff | Jaeger | VYAIRE MEDICAL GMBH |
| 47 | 04250892905136 | 175400 | 175400 | MasterScreen Body/Diff | Jaeger | VYAIRE MEDICAL GMBH |
| 48 | 04250892905129 | V-172521 | V-172521 | MasterScreen PFT | Jaeger | VYAIRE MEDICAL GMBH |
| 49 | 04250892905112 | 172520 | 172520 | MasterScreen PFT | Jaeger | VYAIRE MEDICAL GMBH |
| 50 | 04250892905105 | 172502 | 172502 | MasterScreen PFT | Jaeger | VYAIRE MEDICAL GMBH |