FDA.reportPublic FDA data

Spirometry Sensor

Primary DI
20884838072248
Brand
Spirometry Sensor
Company
Philips Medizin Systeme Böblingen GmbH
Model
Flow Sensor Neonatal
Catalog number
989803144671
Device description
The M2786A in combination with the spirometry module M1014A is designed to allow measurement of airway pressures, flow, minute volume, tidal volume, airway compliance, airway resistance and CO2.
Published
2017-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
20884838072248PrimaryGS10
00884838072244Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088483807224820884838072248
00884838072244008848380722448848380722440884838072244

GMDN Terms#

Term, Definition table
TermDefinition
Monitoring spirometer, electricalA mains electricity (AC-powered) device designed to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status. It may also be used to measure the tidal volume, minute volume, and respiration rate delivered to a patient via the expiratory ports of resuscitation devices, such as transport ventilators and resuscitators, to evaluate their performance. The device may incorporate high and low tidal volume alarms.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure53.3 KiloPascal106.7 KiloPascal
Storage Environment Atmospheric Pressure57 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
314101143
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00884838096745Cardiac WorkstationCardiac Workstation 70008604512026-08-18
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00884838119215Telemetry AccessoriesECG 5L Grabber, IEC, Masimo SpO2 , Tele9898032024212026-05-28
00884838119222Telemetry AccessoriesTelemetry Adapter 6-Lead + Masimo SpO29898032042912026-05-28
00884838094826Cardiac WorkstationCardiac Workstation 50008604392025-01-24
00884838094833Cardiac WorkstationCardiac Workstation 70008604412025-01-24
00884838132320Patient Information Center iXPatient Information Center iX 4.88663892026-07-13
00884838132337Care AssistCare Assist iOS 4.89898032215312026-07-13
00884838132344Care AssistCare Assist Android 4.89898032215412026-07-13
00884838119017Telemetry AccessoriesECG 3 lead Grabber, AAMI + SpO2, Tele9898031718112026-05-28
00884838119024Telemetry AccessoriesECG 5 lead Snaps, AAMI, Tele9898031718212026-05-28
00884838119031Telemetry AccessoriesECG 5 lead Grabber, AAMI, Tele9898031718312026-05-28
00884838119048Telemetry AccessoriesECG 5 lead Snaps, AAMI + SpO2, Tele9898031718412026-05-28
00884838119055Telemetry AccessoriesECG 5 lead Grabber, AAMI + SpO2, Tele9898031718512026-05-28
00884838119062Telemetry AccessoriesECG 6 lead Grabber, AAMI, Tele9898031718612026-05-28
00884838119185Telemetry AccessoriesTelemetry Adapter 5-Lead + Masimo SpO29898032023812026-05-28
00884838119079Telemetry AccessoriesECG 6 lead Grabber, AAMI + SpO2, Tele9898031718712026-05-26
00884838119086Telemetry AccessoriesECG 3 lead Grabber, IEC + SpO2, Tele9898031719112026-05-26

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