FDA.reportPublic FDA data

PeriWatch Vigilance™ HUB™

Primary DI
B087HUB01041
Brand
PeriWatch Vigilance™ HUB™
Company
PERIGEN SOLUTIONS LTD
Model
01.04.xx
Device description
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.
Published
2019-06-04
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980719000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980719000CALMLms Medical Systems , Ltd.1998-07-31HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B087HUB01041PrimaryHIBCC0

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

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