Identity
- Trade Name
- PeriWatch Vigilance® HUB™ FDA UDI
- Generic Name
- Obstetrical monitoring/analysis software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 22.01.xx FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B087HUB22011 FDA UDI
- 510(k) Number
- K980719 FDA UDI
- FDA Product Code
- HGM FDA UDI
- GMDN Term
- Obstetrical monitoring/analysis software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Obstetrical monitoring/analysis software
PeriWatch Vigilance® HUB™ by Perigen Solutions Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K980719 also covers:
- PeriCALM® Tracings™ — PERIGEN SOLUTIONS LTD
- PeriCALM® Tracings™, HUB Module — PERIGEN SOLUTIONS LTD
- PeriWatch Vigilance® HUB™ — PERIGEN SOLUTIONS LTD
- PeriWatch Vigilance® HUB™ — PERIGEN SOLUTIONS LTD
- PeriWatch Vigilance® HUB™ — PERIGEN SOLUTIONS LTD
- PeriWatch Vigilance® HUB™ — PERIGEN SOLUTIONS LTD
- PeriWatch Vigilance® HUB™ — PERIGEN SOLUTIONS LTD
- PeriWatch Vigilance® HUB™ — PERIGEN SOLUTIONS LTD
- PeriWatch Vigilance™ HUB™ — PERIGEN SOLUTIONS LTD
- PeriWatch™ HUB™ — PERIGEN SOLUTIONS LTD
- PeriWatch™ HUB™ — PERIGEN SOLUTIONS LTD
- PeriWatch™ Vigilance™ — PERIGEN SOLUTIONS LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Perigen Solutions Ltd
Sources (1)
- FDA UDI 3ad0e2cf-03d6-4abe-8584-9068b71530c8 35 fields · synced May 30, 2026