OBIX Perinatal Data System - OBIX Perinatal Data System is used in perinatal - Clinical Computer Systems, Inc.

Duns Number:928008213

Device Description: OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Triage). A patient record is populated with information related to perinatal fetal monitor surveillance.

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More Product Details

Catalog Number

-

Brand Name

OBIX Perinatal Data System

Version/Model Number

10.0

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121208

Product Code Details

Product Code

HGM

Product Code Name

System, Monitoring, Perinatal

Device Record Status

Public Device Record Key

e47261e4-9c53-4717-8aae-31c0543f5fdd

Public Version Date

July 29, 2021

Public Version Number

1

DI Record Publish Date

July 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

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