PeriWatch® Cues™

GUDID B087PWCUES02101

PeriWatch® Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥3

PERIGEN SOLUTIONS LTD

Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software

• Primary Device ID: B087PWCUES02101
• NIH Device Record Key: 26de1f07-7008-49e7-b2b1-908fffafe450
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeriWatch® Cues™
• Version Model Number: 02.10.xx
• Company DUNS: 533337713
• Company Name: PERIGEN SOLUTIONS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B087PWCUES02101 [Primary]

FDA Product Code

• HGM: System, Monitoring, Perinatal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-14
• Device Publish Date: 2019-03-06

Devices Manufactured by PERIGEN SOLUTIONS LTD

• B087CURV202411 - PeriWatch Vigilance® Curve™: 2024-04-25 PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presenta
• B087HUB202411 - PeriWatch Vigilance® HUB™: 2024-04-25 PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote
• B087PATT202411 - PeriWatch Vigilance® Cues™: 2024-04-25 PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartu
• B087CURV202221 - PeriWatch Vigilance® Curve™: 2024-01-04 PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presenta
• B087HUB202221 - PeriWatch Vigilance® HUB™: 2024-01-04 PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote
• B087PATT202221 - PeriWatch Vigilance® Cues™: 2024-01-04 PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartu
• B087CURV22011 - PeriWatch Vigilance® Curve™: 2022-09-12 PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presenta
• B087HUB22011 - PeriWatch Vigilance® HUB™: 2022-09-12 PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote