FDA.reportPublic FDA data

Portrait CVAXB

Primary DI
00198953024096
Brand
Portrait CVAXB
Company
Ge Medical Systems Information Technologies, Inc.
Model
CVAXB
Catalog number
5863721-12
Device description
Portrait Central Viewer Application Installer V1.2.0
Published
2025-12-10
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
BZQMonitor, Breathing Frequency
DQAOximeter
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
MSXSystem, Network And Communication, Physiological Monitors
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2
DQAOximeterCardiovascular2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234130000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234130000Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OGe Medical Systems Information Technologies, Inc.2024-03-20MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953024096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953024096001989530240961989530240960198953024096

GMDN Terms#

Term, Definition table
TermDefinition
Wireless patient monitor/sensor reporting software, professional-onlyA software program intended to be installed on an off-the-shelf, computerized device (e.g., desktop computer, tablet) and used by a healthcare professional in a clinical/care setting to receive data from a noninvasive, patient-worn, wireless monitor/sensor. It is not dedicated to bedside monitoring.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118935631
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278840202MAC722270007-0212026-10-13
00840682105521SOFT-CUF24002016-06-30
00840682105712SOFT-CUF24072016-06-30
00840682108287CLASSIC-CUF23522016-06-30
00840682108300CLASSIC-CUF23532016-06-30
00840682108386CLASSIC-CUF23542016-06-30
00840682108393CLASSIC-CUF23562016-06-30
00840682108492CLASSIC-CUF23552016-06-30
00840682108669CLASSIC-CUF26722016-06-30
00840682108683CLASSIC-CUF26752016-06-30
00840682108690CLASSIC-CUF23572016-06-30
00840682108850CLASSIC-CUF26742016-06-30
00840682108911CLASSIC-CUF26732016-06-30
00840682110204DURA-CUF22072016-06-30
00840682110242DURA-CUF22062016-06-30
00840682108713CLASSIC-CUF26702016-06-30
00840682108720CLASSIC-CUF26712016-06-30
00840682117494NA1073632016-06-30
00195278025296CLASSIC-CUFCLA-A2-2A-X-5SCLA-A2-2A-X-5S2021-08-02
00195278990914Portrait CSSXBCSSXB59733402025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
00860011800613CardioTagCARDIOSENSE, INC.DRG2026-10-14
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
07290019919346OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919414OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919421OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919438OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyBZQ2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyBZQ2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyBZQ2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQA2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyBZQ2026-10-04
06946725547168APKAPK Technology Co.,Ltd.DQA2026-09-24
06946725571705APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725571903APKAPK Technology Co.,Ltd.DQA2026-09-20
07290016714265SleepSenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-09-08
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25