PeriCALM® Patterns™ - PeriCALM® Patterns™ is intended for use as an - PERIGEN SOLUTIONS LTD

Duns Number:533337713

Device Description: PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-makin PeriCALM® Patterns™ 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.

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More Product Details

Catalog Number

-

Brand Name

PeriCALM® Patterns™

Version/Model Number

02.08.xx

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code Details

Product Code

HGM

Product Code Name

System, Monitoring, Perinatal

Device Record Status

Public Device Record Key

750d0199-3b74-4aeb-9375-0706d4757d38

Public Version Date

December 24, 2018

Public Version Number

4

DI Record Publish Date

December 18, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PERIGEN SOLUTIONS LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 29