PeriWatch Surveillance

GUDID 00860003483510

PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves as a decision support tool and electronic medical record.

PERIGEN INC.

Obstetrics information system

• Primary Device ID: 00860003483510
• NIH Device Record Key: 1d7862d5-89a5-4a9d-ab83-7823822b0193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeriWatch Surveillance
• Version Model Number: 2021.1.0
• Company DUNS: 080813890
• Company Name: PERIGEN INC.
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003483510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080226

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: 2021-05-10
• Device Publish Date: 2021-04-30

On-Brand Devices [PeriWatch Surveillance]

• 00860003483503: PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System,
• 00860003483510: PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System,
• 00860003483527: PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System,
• 00860003483558: PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management System,