FDA.reportPublic FDA data

SO2 Optical Module

Primary DI
00884838020849
Brand
SO2 Optical Module
Company
Philips Medizin Systeme Böblingen GmbH
Model
SO2 Optical Module
Catalog number
989803151591
Device description
SO2 Optical Module (Type P) for use with M1011A SO2 Module as for intravascular catheters such as scvO2 and svO2. See Instructions for Use for compatible catheters, catheters are not available from Philips.
Published
2018-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZCCalculator, Pulmonary Function Data
BZQMonitor, Breathing Frequency
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
DPSElectrocardiograph
DQAOximeter
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
DRJSystem, Signal Isolation
DRQAmplifier And Signal Conditioner, Transducer Signal
DRSTransducer, Blood-Pressure, Extravascular
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DRWAdaptor, Lead Switching, Electrocardiograph
DSACable, Transducer And Electrode, Patient, (Including Connector)
DSFRecorder, Paper Chart
DSHRecorder, Magnetic Tape, Medical
DSIDETECTOR AND ALARM, ARRHYTHMIA
DSJAlarm, Blood-Pressure
DSKComputer, Blood-Pressure
DSPSystem, Balloon, Intra-Aortic And Control
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLThermometer, Electronic, Clinical
GWSAnalyzer, Spectrum, Electroencephalogram Signal
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
KOIStimulator, Nerve, Peripheral, Electric
KRBProbe, Thermodilution
KRCTester, Electrode, Surface, Electrocardiographic
LKDMonitor, Carbon-Dioxide, Cutaneous
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MLCMonitor, St Segment
MLDMonitor, St Segment With Alarm
MSXSystem, Network And Communication, Physiological Monitors
NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
ORTBurst Suppression Detection Software For Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZCCalculator, Pulmonary Function DataAnesthesiology2
BZQMonitor, Breathing FrequencyAnesthesiology2
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)Anesthesiology2
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)Anesthesiology2
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2
DPSElectrocardiographCardiovascular2
DQAOximeterCardiovascular2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DRJSystem, Signal IsolationCardiovascular1
DRQAmplifier And Signal Conditioner, Transducer SignalCardiovascular2
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DRWAdaptor, Lead Switching, ElectrocardiographCardiovascular2
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
DSFRecorder, Paper ChartCardiovascular1
DSHRecorder, Magnetic Tape, MedicalCardiovascular2
DSIDetector And Alarm, ArrhythmiaCardiovascular2
DSJAlarm, Blood-PressureCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DSPSystem, Balloon, Intra-Aortic And ControlCardiovascular2
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
GWSAnalyzer, Spectrum, Electroencephalogram SignalNeurology1
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas AnesthesiaAnesthesiology2
KOIStimulator, Nerve, Peripheral, ElectricAnesthesiology2
KRBProbe, ThermodilutionCardiovascular2
KRCTester, Electrode, Surface, ElectrocardiographicCardiovascular2
LKDMonitor, Carbon-Dioxide, CutaneousAnesthesiology2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
MLCMonitor, St SegmentCardiovascular2
MLDMonitor, St Segment With AlarmCardiovascular2
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2
NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
ORTBurst Suppression Detection Software For ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150310000IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015-05-13DSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838020849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838020849008848380208498848380208490884838020849

GMDN Terms#

Term, Definition table
TermDefinition
Intracardiac oximeterA mains electricity (AC-powered) photoelectric device designed to transmit radiation at a known wavelength(s) through blood to measure the concentration of oxygen, or dye, within the heart based on the amount of reflected or scattered radiation. It is typically used in conjunction with a fibreoptic oximeter catheter (e.g., a Swan-Ganz catheter) that is introduced via a vein in the groin or neck to measure mixed venous oxygen saturation (SvO2) or evaluate intracardiac shunts.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure27 KiloPascal105 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
314101143
Device count
1
Serial number
true

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00884838132337Care AssistCare Assist iOS 4.89898032215312026-07-13
00884838132344Care AssistCare Assist Android 4.89898032215412026-07-13
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00884838119086Telemetry AccessoriesECG 3 lead Grabber, IEC + SpO2, Tele9898031719112026-05-26
00884838119093Telemetry AccessoriesECG 5 lead Grabber, IEC, Tele9898031719312026-05-26
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