| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B087PATT02081 | 02.08.xx | PeriWatch™ Cues™ is intended for use as an adjunct to qualified clinical decisio PeriWatch™ Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch™ Cues™ | |
| 2 | B087CURV02101 | 02.10.xx | PeriWatch Vigilance Curve is intended for use as a data analysis system to asses PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch™ Vigilance™ Curve™ | |
| 3 | B087VIGILANCE01001 | 01.00.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch™ Vigilance™ | |
| 4 | B087PATT22011 | 22.01.xx | PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch Vigilance® Cues™ | |
| 5 | B087PATT21011 | 21.01.xx | PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch Vigilance® Cues™ | |
| 6 | B087PATT02121 | 02.12.xx | PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch Vigilance® Cues™ | |
| 7 | B087HUB01031 | 01.03.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch™ Vigilance™ HUB™ | |
| 8 | B087TRAC03181 | 03.18.04 | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | HGM | System, Monitoring, Perinatal | 2 | PeriCALM® Tracings™ | |
| 9 | B087PATT02101 | 02.10.xx | PeriWatch™ Vigilance™ Cues™ is intended for use as an adjunct to qualified clini PeriWatch™ Vigilance™ Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch™ Vigilance™ Cues™ | |
| 10 | B087HUB01021 | 01.02.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch™ HUB™ | |
| 11 | B087HUB01011 | 01.01.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch™ HUB™ | |
| 12 | B087PATCL01021 | 01.02.00 | PeriCALM® CheckList™ is intended for use as an adjunct to qualified clinical dec PeriCALM® CheckList™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | HGM | System, Monitoring, Perinatal | 2 | PeriCALM® CheckList™ | |
| 13 | B087CURV22011 | 22.01.xx | PeriWatch Vigilance Curve is intended for use as a data analysis system to asses PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch Vigilance® Curve™ | |
| 14 | B087CURV21011 | 21.01.xx | PeriWatch Vigilance Curve is intended for use as a data analysis system to asses PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch Vigilance® Curve™ | |
| 15 | B087CURV02121 | 02.12.xx | PeriWatch Vigilance Curve is intended for use as a data analysis system to asses PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch Vigilance® Curve™ | |
| 16 | B087CURVE02081 | 02.08.xx | PeriCALM Curve is intended for use as a data analysis system to assess labor pro PeriCALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks. | HGM | System, Monitoring, Perinatal | 2 | PeriCALM® Curve™ | |
| 17 | B087CURV02061 | 02.06.00 | PeriCALM Curve is intended for use as a data analysis system to assess labor pro PeriCALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks. | HGM | System, Monitoring, Perinatal | 2 | PeriCALM® Curve™ | |
| 18 | B087PWCUES02101 | 02.10.xx | PeriWatch® Cues™ is intended for use as an adjunct to qualified clinical decisio PeriWatch® Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch® Cues™ | |
| 19 | B087HUB22011 | 22.01.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch Vigilance® HUB™ | |
| 20 | B087HUB21011 | 21.01.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch Vigilance® HUB™ | |
| 21 | B087HUB01051 | 01.05.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch Vigilance® HUB™ | |
| 22 | B087HUB01001 | 01.00.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | HGM | System, Monitoring, Perinatal | 2 | PeriCALM® Tracings™, HUB Module | |
| 23 | B087HUB01041 | 01.04.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch Vigilance™ HUB™ | |
| 24 | B087CURV02081 | 02.08.xx | PeriWatch Curve is intended for use as a data analysis system to assess labor pr PeriWatch Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch™ Curve™ | |
| 25 | B087PWCURV02101 | 02.10.xx | PeriWatch Curve is intended for use as a data analysis system to assess labor pr PeriWatch Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks. | HGM | System, Monitoring, Perinatal | 2 | PeriWatch® Curve™ | |
| 26 | B087PATTERNS02081 | 02.08.xx | PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical deci PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | HGM | System, Monitoring, Perinatal | 2 | PeriCALM® Patterns™ | |
| 27 | B087PATT02041 | 02.04.xx | PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical deci PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | HGM | System, Monitoring, Perinatal | 2 | PeriCALM® Patterns™ | |
| 28 | B087PATT02021 | 02.02.10 | PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical deci PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | HGM | System, Monitoring, Perinatal | 2 | PeriCALM® Patterns™ |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B321600226110010 | 27" Wall Mount | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 2 | B32160022611001 | 27" Wall Mount | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 3 | B321600226110 | 27" DeskTop | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 4 | B32160022611 | 27" DeskTop | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 5 | B321600226100010 | 27 Wall Mount | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 6 | B321600226100 | 27 DeskTop | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 7 | B321600226000010 | 27 Wall Mount | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 8 | B321600226000 | 27 DeskTop | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 9 | B321600225000010 | 27 Wall Mount | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 10 | B321600225000 | 27 DeskTop | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 11 | B321598226010 | NUC8i3BEK | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 12 | B32159822601 | NUC8i3BEK | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 13 | B321598226000 | 4K 55 | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 14 | B321598225010 | 4K 55 | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 15 | B321598223020 | t5745 | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 16 | B321598223010 | t5545 | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 17 | B321598221010020 | ETCX X98-1 (CM9) | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | ||
| 18 | B321598107300 | UDAS17 | Universal Data Acquisition System | CLINICOMP INTERNATIONAL, INC. | ||
| 19 | B321340226010 | FMRD 4K 55" | 340-22601 | Fetal Monitor Remote Display | CLINICOMP INTERNATIONAL, INC. | |
| 20 | B15320020 | 2002 | AirStrip Cardiology, Patient Monitoring, OB - Client Android | AirStrip ONE | AIRSTRIP TECHNOLOGIES, INC. | |
| 21 | B15320010 | 2001 | AirStrip Cardiology, Patient Monitoring and OB - Client iOS | AirStrip ONE | AIRSTRIP TECHNOLOGIES, INC. | |
| 22 | B15320000 | 2000 | AirStrip Cardiology, Patient Monitoring, OB - Server Platform | AirStrip ONE | AIRSTRIP TECHNOLOGIES, INC. | |
| 23 | B15310010 | 1001 | OB Legacy System iOS Software System | AirStrip OB Legacy iOS | AIRSTRIP TECHNOLOGIES, INC. | |
| 24 | B15310000 | 1000 | OB Legacy System Server Software System | AirStrip OB Legacy Server | AIRSTRIP TECHNOLOGIES, INC. | |
| 25 | B087VIGILANCE01001 | 01.00.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | PeriWatch™ Vigilance™ | PERIGEN SOLUTIONS LTD | |
| 26 | B087TRAC03181 | 03.18.04 | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | PeriCALM® Tracings™ | PERIGEN SOLUTIONS LTD | |
| 27 | B087PWCURV02101 | 02.10.xx | PeriWatch Curve is intended for use as a data analysis system to assess labor pr PeriWatch Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks. | PeriWatch® Curve™ | PERIGEN SOLUTIONS LTD | |
| 28 | B087PWCUES02101 | 02.10.xx | PeriWatch® Cues™ is intended for use as an adjunct to qualified clinical decisio PeriWatch® Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | PeriWatch® Cues™ | PERIGEN SOLUTIONS LTD | |
| 29 | B087PATTERNS02081 | 02.08.xx | PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical deci PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | PeriCALM® Patterns™ | PERIGEN SOLUTIONS LTD | |
| 30 | B087PATT22011 | 22.01.xx | PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | PeriWatch Vigilance® Cues™ | PERIGEN SOLUTIONS LTD | |
| 31 | B087PATT21011 | 21.01.xx | PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | PeriWatch Vigilance® Cues™ | PERIGEN SOLUTIONS LTD | |
| 32 | B087PATT02121 | 02.12.xx | PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | PeriWatch Vigilance® Cues™ | PERIGEN SOLUTIONS LTD | |
| 33 | B087PATT02101 | 02.10.xx | PeriWatch™ Vigilance™ Cues™ is intended for use as an adjunct to qualified clini PeriWatch™ Vigilance™ Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | PeriWatch™ Vigilance™ Cues™ | PERIGEN SOLUTIONS LTD | |
| 34 | B087PATT02081 | 02.08.xx | PeriWatch™ Cues™ is intended for use as an adjunct to qualified clinical decisio PeriWatch™ Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | PeriWatch™ Cues™ | PERIGEN SOLUTIONS LTD | |
| 35 | B087PATT02061 | 02.06.00 | PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical deci PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | PeriCALM® Patterns™ | PERIGEN SOLUTIONS LTD | |
| 36 | B087PATT02041 | 02.04.xx | PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical deci PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | PeriCALM® Patterns™ | PERIGEN SOLUTIONS LTD | |
| 37 | B087PATT02021 | 02.02.10 | PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical deci PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | PeriCALM® Patterns™ | PERIGEN SOLUTIONS LTD | |
| 38 | B087PATCL01021 | 01.02.00 | PeriCALM® CheckList™ is intended for use as an adjunct to qualified clinical dec PeriCALM® CheckList™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. | PeriCALM® CheckList™ | PERIGEN SOLUTIONS LTD | |
| 39 | B087HUB22011 | 22.01.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | PeriWatch Vigilance® HUB™ | PERIGEN SOLUTIONS LTD | |
| 40 | B087HUB21011 | 21.01.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | PeriWatch Vigilance® HUB™ | PERIGEN SOLUTIONS LTD | |
| 41 | B087HUB01051 | 01.05.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | PeriWatch Vigilance® HUB™ | PERIGEN SOLUTIONS LTD | |
| 42 | B087HUB01041 | 01.04.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | PeriWatch Vigilance™ HUB™ | PERIGEN SOLUTIONS LTD | |
| 43 | B087HUB01031 | 01.03.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | PeriWatch™ Vigilance™ HUB™ | PERIGEN SOLUTIONS LTD | |
| 44 | B087HUB01021 | 01.02.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | PeriWatch™ HUB™ | PERIGEN SOLUTIONS LTD | |
| 45 | B087HUB01011 | 01.01.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | PeriWatch™ HUB™ | PERIGEN SOLUTIONS LTD | |
| 46 | B087HUB01001 | 01.00.xx | PeriCALM® Tracings™ is intended for use as a central monitoring system with sign PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions. | PeriCALM® Tracings™, HUB Module | PERIGEN SOLUTIONS LTD | |
| 47 | B087CURVE02081 | 02.08.xx | PeriCALM Curve is intended for use as a data analysis system to assess labor pro PeriCALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks. | PeriCALM® Curve™ | PERIGEN SOLUTIONS LTD | |
| 48 | B087CURV22011 | 22.01.xx | PeriWatch Vigilance Curve is intended for use as a data analysis system to asses PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks. | PeriWatch Vigilance® Curve™ | PERIGEN SOLUTIONS LTD | |
| 49 | B087CURV21011 | 21.01.xx | PeriWatch Vigilance Curve is intended for use as a data analysis system to asses PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks. | PeriWatch Vigilance® Curve™ | PERIGEN SOLUTIONS LTD | |
| 50 | B087CURV02121 | 02.12.xx | PeriWatch Vigilance Curve is intended for use as a data analysis system to asses PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks. | PeriWatch Vigilance® Curve™ | PERIGEN SOLUTIONS LTD |