FDA.reportPublic FDA data

PeriWatch® Cues™

Primary DI
B087PWCUES02101
Brand
PeriWatch® Cues™
Company
PERIGEN SOLUTIONS LTD
Model
02.10.xx
Device description
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.
Published
2019-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B087PWCUES02101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical monitoring/analysis softwareA software program intended to facilitate clinical management of pregnancy and/or labour by providing functionality in one or more of the following areas: data acquisition, recording, analysis, and reporting. It typically processes maternal and/or foetal physiologic parameters [e.g., maternal heart rate (MHR) and foetal heart rate (FHR), maternal oxygen saturation (SpO2) and temperature, intrapartum foetal oxygen saturation (FSpO2), intrauterine/amniotic pressure], and is intended to be used in conjunction with specialized monitors in the maternity unit.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8552364353support@perigen.com

Regulatory Flags#

DUNS number
533337713
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B087CURV202511PeriWatch Vigilance® Curve™ 2025.1.xxx2025-06-11
B087HUB202511PeriWatch Vigilance® HUB™2025.1.xxx2025-06-11
B087PATT202511PeriWatch Vigilance® Cues™2025.1.xxx2025-06-11
B087CURV202421PeriWatch Vigilance® Curve™ 2024.2.xxx2024-10-08
B087HUB202421PeriWatch Vigilance® HUB™2024.2.xxx2024-10-08
B087PATT202421PeriWatch Vigilance® Cues™2024.2.xxx2024-10-08
B087CURV202411PeriWatch Vigilance® Curve™ 2024.1.xxx2024-04-17
B087HUB202411PeriWatch Vigilance® HUB™2024.1.xxx2024-04-17
B087PATT202411PeriWatch Vigilance® Cues™2024.1.xxx2024-04-17
B087CURV202221PeriWatch Vigilance® Curve™ 2022.2.xxx2023-12-27
B087HUB202221PeriWatch Vigilance® HUB™2022.2.xxx2023-12-27
B087PATT202221PeriWatch Vigilance® Cues™2022.2.xxx2023-12-27
B087CURV22011PeriWatch Vigilance® Curve™ 22.01.xx2022-09-04
B087HUB22011PeriWatch Vigilance® HUB™22.01.xx2022-09-04
B087PATT22011PeriWatch Vigilance® Cues™22.01.xx2022-09-04
B087CURV21011PeriWatch Vigilance® Curve™ 21.01.xx2021-07-21
B087HUB21011PeriWatch Vigilance® HUB™21.01.xx2021-07-21
B087PATT21011PeriWatch Vigilance® Cues™21.01.xx2021-07-21
B087CURV02121PeriWatch Vigilance® Curve™ 02.12.xx2020-08-11
B087HUB01051PeriWatch Vigilance® HUB™01.05.xx2020-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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B153301020AirStrip ONE Client AndroidAirstrip Technologies, Inc.HGM2026-03-18
05051968048233SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048240SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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05051968048431OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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06944413819733Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413807112Remote Event MarkerEdan Instruments, Inc.HGM2025-11-29
00860003483565PeriWatch SurveillancePERIGEN INC.HGM2025-11-24
00198953043271CareIntellect PerinatalGe Medical Systems Information Technologies, Inc.HGM2025-11-21