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PeriWatch Tracings

FDA UDI

Class II (US FDA UDI)

by Perigen Inc.

Identity

Trade Name
PeriWatch Tracings FDA UDI
Generic Name
Obstetrics information system application software FDA UDI
Device Name
PeriWatch Vigilance Tracings 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 a a decision support tool and electronic medical record. FDA UDI
Model / Reference
2018 Rev 1.00 FDA UDI
Description
PeriWatch Vigilance Tracings 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 a a decision support tool and electronic medical record. FDA UDI

Identifiers

Primary DI / UDI-DI
00862095000439 FDA UDI
510(k) Number
K080226 FDA UDI
FDA Product Code
HGM FDA UDI
GMDN Term
Obstetrics information system application 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Obstetrics information system application software

PeriWatch Tracings by Perigen Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Obstetrics information system application software.

Cleared under the same submission

K080226 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Perigen Inc.

Sources (1)

  • FDA UDI 72746b19-fd5e-4845-90c7-e108f5806962 35 fields · synced May 30, 2026