PeriCALM Patterns 3.0
Perigen, Inc.
Perigen, Inc.
PMN#
GUDID#
PeriWatch Surveillance - PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves as a decision support tool and electronic medical record.
2025-11-24
PeriWatch Vigilance® Curve™ - 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.
2025-06-11
PeriWatch Vigilance® Cues™ - 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.
2025-06-11
PeriWatch Vigilance® HUB™ - 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.
2025-06-11
PeriWatch Vigilance® Curve™ - 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.
2024-10-08
PeriWatch Vigilance® HUB™ - 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.
2024-10-08
PeriWatch Vigilance® Cues™ - 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.
2024-10-08
PeriWatch Surveillance - PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves as a decision support tool and electronic medical record.
2024-05-13
PeriWatch Vigilance® Curve™ - 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.
2024-04-17
PeriWatch Vigilance® HUB™ - 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.
2024-04-17
PeriWatch Vigilance® Cues™ - 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.
2024-04-17
PeriWatch Vigilance® HUB™ - 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.
2023-12-27
PeriWatch Vigilance® Cues™ - 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.
2023-12-27
PeriWatch Vigilance® Curve™ - 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.
2023-12-27
PeriWatch Surveillance - 2022.1.002
2023-07-13
PeriWatch Surveillance - PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves as a decision support tool and electronic medical record.
2023-01-03
PeriWatch Vigilance® Curve™ - 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.
2022-09-04
PeriWatch Vigilance® HUB™ - 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.
2022-09-04
PeriWatch Vigilance® Cues™ - 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.
2022-09-04
PeriWatch Surveillance - PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves as a decision support tool and electronic medical record.
2021-12-31
PeriWatch Vigilance® Curve™ - 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.
2021-07-21
PeriWatch Vigilance® Cues™ - 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.
2021-07-21
PeriWatch Vigilance® HUB™ - 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.
2021-07-21
PeriWatch Surveillance - PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves as a decision support tool and electronic medical record.
2021-04-30
PeriWatch Vigilance® Curve™ - 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.
2020-08-11
PeriWatch Vigilance® HUB™ - 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.
2020-08-11
PeriWatch Vigilance® Cues™ - 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.
2020-08-11
PeriWatch Surveillance - PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves a a decision support tool and electronic medical record.
2020-06-30
PeriWatch™ Vigilance™ HUB™ - 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.
2018-11-12
PeriCALM® Curve™ - 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.
2016-05-30
PeriWatch™ Curve™ - 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.
2017-06-22
PeriWatch™ Vigilance™ Curve™ - 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.
2018-11-12
PeriCALM® Curve™ - 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.
2017-12-18
PeriWatch™ HUB™ - 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.
2017-12-18
PeriWatch™ HUB™ - 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.
2018-09-16
PeriCALM® Tracings™, HUB Module - 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.
2017-07-09
PeriWatch® Curve™ - 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.
2019-03-06
PeriCALM® Tracings™ - 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.
2016-05-30
PeriWatch™ Vigilance™ - 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.
2018-11-12
PeriWatch Vigilance Tracings - PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves a a decision support tool and electronic medical record.
2019-10-30