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
00840682119269NA3300782016-07-15
00840682119276NA3300882016-06-30
00840682104852NA2017098-0012016-07-22
00840682108928ApexProCH Transmitter2016-06-10
00840682109383CARESCAPET14 Transmitter2016-06-10
00840682116602NA2017008-0032016-07-15
00840682105491SOFT-CUFSFT-F1-2E2016-06-30
00840682106818SOFT-CUF21262016-06-30
00840682107150SOFT-CUF2362-INT2362-INT2016-06-30
00840682108805CLASSIC-CUF23592016-06-30
00840682108874CLASSIC-CUF23582016-06-30
00840682109215CLASSIC-CUF21382016-06-30
00840682109291CLASSIC-CUF21332016-06-30
00840682109307CLASSIC-CUF21192016-06-30
00840682109437CLASSIC-CUF230723072016-06-30
00840682109635CLASSIC-CUF230223022016-06-30
00840682109710CLASSIC-CUF230523052016-06-30
00840682110778SENSA-CUF24702016-06-30
00840682110792SENSA-CUF24622016-06-30
00840682110822SENSA-CUF24642016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109875Ventilator accessorySunset Healthcare Solutions, Inc.BZO2026-10-27
06946725572900APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725572948APKAPK Technology Co.,Ltd.DQA2026-10-26
B353LP1251E1LifeSignalsLifesignals, Inc.DRG2026-10-26
06946725516812APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516829APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516836APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516843APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516850APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516867APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516874APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516881APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516898APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516904APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516911APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516928APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516935APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516942APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516959APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516966APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516973APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516980APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516997APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517000APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517017APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517024APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517031APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517048APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517055APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517062APKAPK Technology Co.,Ltd.DQA2026-03-12