PeriWatch Surveillance

GUDID 00860003483558

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.

PERIGEN INC.

Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system Obstetrics information system
Primary Device ID00860003483558
NIH Device Record Key4ce9be0c-6858-4b5d-adda-ec3fff52636e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeriWatch Surveillance
Version Model Number2024.1.000
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
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com
Phone855-236-4353
Emailsupport@perigen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003483558 [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 Date2024-05-21
Device Publish Date2024-05-13

On-Brand Devices [PeriWatch Surveillance]

00860003483503PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System,
00860003483510PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System,
00860003483527PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System,
00860003483558PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System,
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