PeriWatch Vigilance® Curve™

GUDID B087CURV202411

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

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• Primary Device ID: B087CURV202411
• NIH Device Record Key: 23355bc4-ab9e-47f2-a7a7-1f82c7519ebc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeriWatch Vigilance® Curve™
• 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: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com
• Phone: 8663216788
• Email: support@perigen.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B087CURV202411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052715

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® Curve™ ]

• B087CURV02121: PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress
• B087CURV21011: PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress
• B087CURV22011: PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress
• B087CURV202221: PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress
• B087CURV202411: PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress