FDA.reportPublic FDA data

NA

Primary DI
00840682104081
Brand
NA
Company
GE Healthcare Finland Oy
Model
E-PSMP-01
Published
2016-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSELECTROCARDIOGRAPH
DPZOximeter, ear
DQAOximeter
DRQAMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
DSKCOMPUTER, BLOOD-PRESSURE
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
FLLThermometer, electronic, clinical
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
MLDMONITOR, ST SEGMENT WITH ALARM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DPZOximeter, EarCardiovascular2
DQAOximeterCardiovascular2
DRQAmplifier And Signal Conditioner, Transducer SignalCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
MLDMonitor, St Segment With AlarmCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043551000DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIESDatex-Ohmeda2005-02-18MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682104081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682104081008406821040818406821040810840682104081

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-5120xx@xx.xx

Regulatory Flags#

DUNS number
401966697
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682103022OxyTip SpO2OXY-FMR-002016-06-16
00840682103077OxyTip SpO2OXY-WMR-002016-06-16
00195278949752TruSignal SpO2 MM 3.0M159769772026-10-04
00195278949769TruSignal SpO2 MM 1.8M159560152026-10-04
00198953002186Carescape Dock F0157006022026-10-04
00840682106498Mobile CareWeb Viewer2016-06-21
00198953009567Carescape ONE259560312026-10-04
00840682102957EntropyGE Entropy sensor, M10386812016-08-15
00840682102971EntropyEasyFit sensor, M11744132016-08-15
00840682102964EntropyEntropy Cable, M1050784M10507842016-06-30
00840682103015NAPiCCO Injectate Sensor Cable2016-06-10
00840682103039NAPiCCO Continuous Cardiac Output Cable2016-06-16
00840682102841NAD-Lite Spirometry Kit 3m/10ft, 80043822016-08-15
00840682102858NAPedi-Lite Spirometry Kit 3m, M10326342016-08-15
00840682102865NAPedi-lite Spirometry Kit 2m, 80027182016-08-15
00840682102926NAMini D-fend Water Trap, 800217480021742016-08-12
00840682102896NACalibration Gas, 7555872016-06-10
00840682102902NACalibration Gas, 755571-HEL2016-06-10
00198953049181NAPiCCO Continuous Cardiac Output Cable2026-01-05
00195278697165PORTRAIT HSWXBHSWXB5700219-112024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016681507UNIVERHEALTHHangzhou Universal Electronic Co.,Ltd.FLL2026-10-28
04719872982296QT ECGQt Medical, Inc.DPS2026-10-28
04719872982302QT ECGQt Medical, Inc.DPS2026-10-28
00816396023680Model 7800EPIVY BIOMEDICAL SYSTEMS, INC.DRT2026-10-27
00816396023697Model 7800EP FRUIVY BIOMEDICAL SYSTEMS, INC.DRT2026-10-27
08800159500060S-Patch CardioAIWellysis Corp.DPS2026-10-27
04048675786320Infinity M540DRAEGER MEDICAL SYSTEMS, INC.MHX2026-10-26
06946725572900APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725572948APKAPK Technology Co.,Ltd.DQA2026-10-26
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