PeriWatch Vigilance® Curve™

GUDID B087CURV202421

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.

PERIGEN SOLUTIONS LTD

Obstetrical monitoring/analysis software
Primary Device IDB087CURV202421
NIH Device Record Keyb672e042-b744-4b1f-bea4-808f7879fc8b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeriWatch Vigilance® Curve™
Version Model Number2024.2.xxx
Company DUNS533337713
Company NamePERIGEN SOLUTIONS LTD
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 Batchtrue
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

Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com
Phone8663216788
Emailsupport@perigen.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB087CURV202421 [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 Date2024-10-16
Device Publish Date2024-10-08

On-Brand Devices [PeriWatch Vigilance® Curve™ ]

B087CURV02121PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress
B087CURV21011PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress
B087CURV22011PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress
B087CURV202221PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress
B087CURV202411PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress
B087CURV202421PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress

Trademark Results [PeriWatch Vigilance]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PERIWATCH VIGILANCE
PERIWATCH VIGILANCE
87979762 not registered Live/Pending
PeriGen, Inc.
2017-12-15
PERIWATCH VIGILANCE
PERIWATCH VIGILANCE
87723083 not registered Live/Pending
PeriGen, Inc.
2017-12-15

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