FDA.reportPublic FDA data

PORTRAIT RR P-RR01

Primary DI
00195278264817
Brand
PORTRAIT RR P-RR01
Company
GE Healthcare Finland Oy
Model
P-RR01
Catalog number
2103567-001
Device description
PORTRAIT RR P-RR FINAL DEVICE ASSEMBLY
Published
2023-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
00195278264817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278264817001952782648171952782648170195278264817

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic physiological parameter ambulatory processor/transmitterAn ambulatory, electrically-powered device designed to be connected to a thorax-placed electrode array (not included) to collect, process, and wirelessly transmit signal data pertaining to a cardiothoracic physiological parameter [e.g., respiration rate, electrocardiogram (ECG)] for subsequent display on a separate monitor. It is a small unit, with electrode connecting cables, designed to be carried/worn by the patient (e.g., attached to a belt). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
401966697
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278699923PORTRAIT MMP01MMP015514246-302023-10-26
00195278110435PORTRAIT MMP01MMP0155142462023-09-01
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
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00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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