PeriWatch Tracings

GUDID 00862095000484

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.

PERIGEN INC.

Obstetrics information system application software
Primary Device ID00862095000484
NIH Device Record Key4edca7c1-a593-4613-b0c5-9505aaff37f1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeriWatch Tracings
Version Model Number2019 Rev 1.02
Company DUNS080813890
Company NamePERIGEN INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-236-4353
Emailsupport@perigen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100862095000484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGMSystem, Monitoring, Perinatal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-09
Device Publish Date2019-10-01

On-Brand Devices [PeriWatch Tracings]

00862095000477PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management Sy
00862095000453PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management Sy
00862095000439PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management Sy
00862095000422PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management Sy
00862095000415PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management Sy
00862095000408PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management Sy
00862095000484PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management Sy

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