FDA.reportPublic FDA data

Portrait CAU01

Primary DI
00840682139250
Brand
Portrait CAU01
Company
GE Medical Systems Information Technologies, Inc.
Model
CAU01
Catalog number
2102549-001
Device description
Portrait Clinical Alarming Unit CAU01
Published
2023-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
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
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1
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
K230626000
K234130000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230626000Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™Ge Medical Systems Information Technologies, Inc.2023-08-11MWI
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
00840682139250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682139250008406821392508406821392500840682139250

GMDN Terms#

Term, Definition table
TermDefinition
Physiologic monitoring system alarmAn electronic device intended to be connected to a physiologic monitoring system to provide an audible and/or visual indicator, in the event of out-of-range parameter detection, to notify medical staff that (urgent) assistance is needed by the patient. It is used by medical professionals and caregivers in the healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006580799
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953213063ComboLabAltiX XI2500000-0052026-08-26
00198953213087CardioLabAltiX XI2500000-0042026-08-26
00198953213094Mac-LabAltiX XI2500000-0032026-08-26
00198953243626MLCL Client SoftwareAltiX XI60147432026-08-26
00195278659446Portrait CSSXBCSSXB59335392024-04-30
00195278343383CARESCAPE CENTRAL STATIONMAI8005867474-032026-02-11
00195278343512CARESCAPE CENTRAL STATIONMAI8005867474-042026-02-11
00195278364661CardioSoftV7.02006300-1122025-03-25
00195278458070MUSENX R24101010-0022022-11-10
00195278025296CLASSIC-CUFCLA-A2-2A-X-5SCLA-A2-2A-X-5S2021-08-02
00198953205716CARESCAPE Telemetry ServerV62026-06-05
00840682180689NAB1X5-REC2021-03-02
00840682140935N/AB1X5-F22104800-0012020-11-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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.MSX2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06924054300920BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880031UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
00840118620987Endure IndustriesENDURE INDUSTRIESDQA2026-08-14
06946725572078APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572085APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572092APKAPK Technology Co.,Ltd.DQA2026-08-14
14026704929204GIBECKTELEFLEX INCORPORATEDBZO2026-08-01
06924054300906BERRYSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-07-30
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