PeriWatch Vigilance® HUB™
GUDID B087HUB202421
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
Obstetrical monitoring/analysis software| Primary Device ID | B087HUB202421 |
| NIH Device Record Key | c7e0c0b9-807f-42a1-bb06-8b83d8ebeb75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PeriWatch Vigilance® HUB™ |
| Version Model Number | 2024.2.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 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com | |
| Phone | 8552364353 |
| support@perigen.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B087HUB202421 [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 | 2024-10-16 |
| Device Publish Date | 2024-10-08 |
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 |
| B087HUB202421 | PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis a |
| B087HUB202511 | PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis a |
Trademark Results [PeriWatch Vigilance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERIWATCH VIGILANCE 87979762 not registered Live/Pending |
PeriGen, Inc. 2017-12-15 |
 PERIWATCH VIGILANCE 87723083 not registered Live/Pending |
PeriGen, Inc. 2017-12-15 |
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