PeriWatch Vigilance® HUB™

GUDID B087HUB202411

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.

PERIGEN SOLUTIONS LTD

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• Primary Device ID: B087HUB202411
• NIH Device Record Key: ddc1b7c7-61c2-4622-9446-75a03b43d335
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeriWatch Vigilance® HUB™
• Version Model Number: 2024.1.xxx
• 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
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com
• Phone: 8552364353
• Email: support@perigen.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B087HUB202411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980719

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: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [PeriWatch Vigilance® HUB™]

• B087HUB01051: PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis a
• B087HUB21011: PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis a
• B087HUB22011: PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis a
• B087HUB202221: PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis a
• B087HUB202411: PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis a