PeriWatch Surveillance - PeriWatch Surveillance is intended to be used as - PERIGEN INC.

Duns Number:080813890

Device Description: PeriWatch Surveillance is intended to be used as a complete Obstetrical Data Management Sy 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 a a decision support tool and electronic medical record.

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More Product Details

Catalog Number

-

Brand Name

PeriWatch Surveillance

Version/Model Number

2020 Rev 1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K080226

Product Code Details

Product Code

HGM

Product Code Name

System, Monitoring, Perinatal

Device Record Status

Public Device Record Key

dffe307b-79e9-4dd2-8f10-b31270f0c0e7

Public Version Date

July 08, 2020

Public Version Number

1

DI Record Publish Date

June 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PERIGEN INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13