FDA.reportPublic FDA data

Avalon Ultrasound Transducer

Primary DI
00884838093195
Brand
Avalon Ultrasound Transducer
Company
Philips Medizin Systeme Böblingen GmbH
Model
Avalon Ultrasound Transducer
Catalog number
867246
Device description
The device is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates
Published
2021-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
DRQAmplifier And Signal Conditioner, Transducer Signal
DRSTransducer, Blood-Pressure, Extravascular
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DSACable, Transducer And Electrode, Patient, (Including Connector)
DSFRecorder, Paper Chart
DSIDetector And Alarm, Arrhythmia
DSJAlarm, Blood-Pressure
DSKComputer, Blood-Pressure
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXQBlood Pressure Cuff
FLLThermometer, Electronic, Clinical
HFMMonitor, Uterine Contraction, External (For Use In Clinic)
HFNTransducer, Pressure, Intrauterine
HGLTransducer, ultrasonic, obstetric
HGMSystem, Monitoring, Perinatal
JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
MSXSystem, Network And Communication, Physiological Monitors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DRQAmplifier And Signal Conditioner, Transducer SignalCardiovascular2
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
DSFRecorder, Paper ChartCardiovascular1
DSIDetector And Alarm, ArrhythmiaCardiovascular2
DSJAlarm, Blood-PressureCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
DXQBlood Pressure CuffCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
HFMMonitor, Uterine Contraction, External (For Use In Clinic)Obstetrics/Gynecology2
HFNTransducer, Pressure, IntrauterineObstetrics/Gynecology2
HGLTransducer, Ultrasonic, ObstetricObstetrics/Gynecology2
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2
JOMPlethysmograph, Photoelectric, Pneumatic Or HydraulicCardiovascular2
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838093195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838093195008848380931958848380931950884838093195

GMDN Terms#

Term, Definition table
TermDefinition
Foetal Doppler system probeA hand-operated component of a foetal Doppler system which is placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure16 KiloPascal107.5 KiloPascal
Storage Environment Atmospheric Pressure57 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Humidity15 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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838118898IECGIntelliSpace ECG Management System - B.028604262026-06-23
10884838117874MR Patient Care Pediatric SpO2 ClipPediatric SpO2 Clip9898031665412025-05-22
10884838117867MR Patient Care Adult SpO2 ClipAdult SpO2 Clip9898031665312025-05-19
00884838091412EarlyVue VS30EarlyVue VS30 Vitals monitor8633802020-03-23
00884838120358Thermal Printer Kit, USBThermal Printer Kit, USB9898032050112026-06-04
00884838073715NMT cableIntelliVue NMT Patient Cable9898031745812017-03-21
00884838111462MR Patient Care Wireless ECG 3.0 Module (Networks 6-10)Wireless ECG 3.0 Module (Networks 6-10)9898031943412025-06-02
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
00884838119192Telemetry AccessoriesTelemetry Adapter Masimo SpO2-only9898032023912026-05-28
00884838119208Telemetry AccessoriesECG 5L Grabber, AAMI, Masimo SpO2 , Tele9898032024112026-05-28
00884838119215Telemetry AccessoriesECG 5L Grabber, IEC, Masimo SpO2 , Tele9898032024212026-05-28
00884838119222Telemetry AccessoriesTelemetry Adapter 6-Lead + Masimo SpO29898032042912026-05-28
00884838119079Telemetry AccessoriesECG 6 lead Grabber, AAMI + SpO2, Tele9898031718712026-05-26
00884838119086Telemetry AccessoriesECG 3 lead Grabber, IEC + SpO2, Tele9898031719112026-05-26

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