FDA.reportPublic FDA data

OBIX Perinatal Data System

Primary DI
00868102000423
Brand
OBIX Perinatal Data System
Company
Clinical Computer Systems, Inc.
Model
8.1
Device description
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.
Published
2021-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121208000OBIX PERINATAL DATA SYSTEM 7.0Clinical Computer Systems, Inc.2012-06-14HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868102000423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868102000423008681020004238681020004230868102000423

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
928008213
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868102000447OBIX Perinatal Data System9.02024-03-29
00868102000416OBIX Perinatal Data System10.02021-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B153301020AirStrip ONE Client AndroidAirstrip Technologies, Inc.HGM2026-03-18
05051968048233SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048240SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048257SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048264SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048271SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048288SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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05051968048417OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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05051968048431OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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06944413819726Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
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06944413807112Remote Event MarkerEdan Instruments, Inc.HGM2025-11-29
00860003483565PeriWatch SurveillancePERIGEN INC.HGM2025-11-24
00198953043271CareIntellect PerinatalGe Medical Systems Information Technologies, Inc.HGM2025-11-21