Identity
- Trade Name
- PeriWatch® Cues™ FDA UDI
- Generic Name
- Obstetrical monitoring/analysis software FDA UDI
- Device Name
- PeriWatch® 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. FDA UDI
- Model / Reference
- 02.10.xx FDA UDI
- Description
- PeriWatch® 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B087PWCUES02101 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® Cues™ by Perigen Solutions Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 26de1f07-7008-49e7-b2b1-908fffafe450 34 fields · synced May 29, 2026