FDA.reportPublic FDA data

PORTRAIT MMP01

Primary DI
00195278110435
Brand
PORTRAIT MMP01
Company
GE Healthcare Finland Oy
Model
MMP01
Catalog number
5514246
Device description
Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS
Published
2023-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00195278110435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278110435001952781104351952781104350195278110435

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
401966697
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278264817PORTRAIT RR P-RR01P-RR012103567-0012023-09-01
00195278699923PORTRAIT MMP01MMP015514246-302023-10-26
00840682103152TruSignal SpO2TS-F2-GE2016-06-16
00840682147811CARESCAPE Software3.2NA2026-04-15
00195278093998PORTRAIT HUB01HUB012096437-0012023-09-01
00198953049181NAPiCCO Continuous Cardiac Output Cable2026-01-05
00198953066560NAPiCCO Injectate Sensor Cable2026-01-05
00198953030981PORTRAIT HSWXBV1.25700672-122025-12-10
00840682136402NACardiac Output Cable, 2.4 m/8 ft.2104180-0022018-08-10
00840682102872NAD-lite Spirometry Kit 2m 7ft, 80043812016-08-15
00840682103169TruSignal SpO2TS-F4-MC2016-07-15
00840682103190TruSignal SpO2TS-F4-N2016-06-16
00840682103343TruSignal SpO2TS-F1-H2016-06-16
00840682103367TruSignal SpO2TS-E4-H2016-06-16
00840682103381TruSignal SpO2TS-E4-N2016-06-16
00840682103442NAPre-conf. EEG Lead Set 2 General, 8980512016-06-16
00840682136358NAInvasive Blood Pressure Cable, Argon, Single, 1.2 2104166-0022018-08-10
00840682136365NAInvasive Blood Pressure Cable, Utah/Biotrans, Sing2104107-0022018-08-13
00840682136464NAInvasive Blood Pressure Cable, Utah/Biotrans, Dual2104107-0042018-08-10
00840682136501NAInvasive Blood Pressure Cable, ICU Medical Transpa2104158-0042018-08-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyMWI2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyMWI2026-07-21
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03615041990578Capsule SurveillancePhilips North America LLCMWI2026-07-14
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-07-13
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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