PeriWatch Vigilance® Cues™

GUDID B087PATT202411

PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.

PERIGEN SOLUTIONS LTD

Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software Obstetrical monitoring/analysis software

• Primary Device ID: B087PATT202411
• NIH Device Record Key: 66686779-df15-4093-b1ae-86df1d7cb996
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeriWatch Vigilance® Cues™
• 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	B087PATT202411 [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: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [PeriWatch Vigilance® Cues™]

• B087PATT02121: PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making
• B087PATT21011: PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making
• B087PATT22011: PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making
• B087PATT202221: PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making
• B087PATT202411: PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making