FDA.reportPublic FDA data

CareIntellect Perinatal

Primary DI
00198953043271
Brand
CareIntellect Perinatal
Company
Ge Medical Systems Information Technologies, Inc.
Model
2.3
Catalog number
K2504AA
Device description
MD CareIntellect Perinatal v2.3
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K220732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220732000Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.2022-06-23HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953043271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953043271001989530432711989530432710198953043271

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information systemA dedicated assembly of devices designed 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. The system 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. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

Regulatory Flags#

DUNS number
118935631
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278620873MAC72119091-0012026-03-31
00840682122504N/A420915-0692016-12-14
00840682122528N/A420915-0112016-12-13
00195278507037Mac-LabAltiX2300000-0032026-03-26
00195278507044CardioLabAltiX2300000-0042022-05-01
00195278507051ComboLabAltiX2300000-0052022-05-01
00195278507525MLCL Client SoftwareAltiX58896052022-05-01
00195278516015MLCL UpgradeAltiX58965972022-05-01
00195278330413Portrait CVA01CVA0158637212023-09-01
00195278341129Portrait CSS01CSS0158708572023-09-01
00840682104814NA2017098-0072016-07-22
00840682104845NA2017098-0032016-07-22
00840682104852NA2017098-0012016-07-22
00840682104869NA2017098-0052016-07-22
00840682109260CARESCAPETelemetry Server V42016-06-10
00840682104784N/APatient Data Module2016-05-27
00840682108775CARESCAPETelemetry Server v4 upgrade2016-06-10
00840682108799ApexPro600 MHz Receiver2016-06-10
00840682108928ApexProCH Transmitter2016-06-10
00840682109024ApexProFH Transceiver2016-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.HGM2026-03-18
B153301010AirStrip ONE Client iOSAirstrip Technologies, Inc.HGM2026-03-18
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
05051968048295OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048301OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048318OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048325OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048332OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048349OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048356OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048363OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048370OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048387OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048394OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048400OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048417OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048424OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048431OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
06944413814714Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413819726Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413819733Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413807112Remote Event MarkerEdan Instruments, Inc.HGM2025-11-29
00860003483565PeriWatch SurveillancePERIGEN INC.HGM2025-11-24
06944413837102Fetal & maternal monitorEdan Instruments, Inc.HGM2025-10-30