FDA.reportPublic FDA data

Portrait CSS01

Primary DI
00195278341129
Brand
Portrait CSS01
Company
GE Medical Systems Information Technologies, Inc.
Model
CSS01
Catalog number
5870857
Device description
PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
Published
2023-09-01
Public version status
Update
Distribution status
Not 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
K230626000

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278341129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278341129001952783411291952783411290195278341129

GMDN Terms#

Term, Definition table
TermDefinition
Bedside information system application softwareAn application software program, routines, and/or algorithms intended to be 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 provision and utilization of administrative and clinical information at the patient's bedside. It is typically supplied for installation into a dedicated information system used at the patient's bedside or existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006580799
Device count
1
Lot or batch
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

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Primary DI, Brand, Company table
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076401218816401ST274-100 LuMon™ Belt Size 26SenTec AGBZQ2026-10-26
076401218816571ST275-100 LuMon™ Belt Size 30SenTec AGBZQ2026-10-26
076401218816641ST276-100 LuMon™ Belt Size 35SenTec AGBZQ2026-10-26
076401218816711ST277-100 LuMon™ Belt Size 40SenTec AGBZQ2026-10-26
076401218816881ST278-100 LuMon™ Belt Size 47SenTec AGBZQ2026-10-26
076401218816951ST282-100 LuMon™ Belt Size 80SenTec AGBZQ2026-10-26
076401218817011ST283-100 LuMon™ Belt Size 92SenTec AGBZQ2026-10-26
076401218817181ST284-100 LuMon™ Belt Size 104SenTec AGBZQ2026-10-26
076401218817251ST285-100 LuMon™ Belt Size 116SenTec AGBZQ2026-10-26
076401218817631ST120-100 LuMon™ Connector 2.0SenTec AGBZQ2026-10-26
B353LP1251E1LifeSignalsLifesignals, Inc.DRG2026-10-26
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