FDA.reportPublic FDA data

Avalon US Transducer

Primary DI
00884838002722
Brand
Avalon US Transducer
Company
Philips Medizin Systeme Böblingen GmbH
Model
Avalon US Transducer
Catalog number
989803143691
Device description
Avalon US Transducer
Published
2016-10-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGLTRANSDUCER, ULTRASONIC, OBSTETRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGLTransducer, Ultrasonic, ObstetricObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140535000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140535000PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50Philips Medizin Systeme Boblingen GmbH2014-11-25HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838002722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838002722008848380027228848380027220884838002722

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
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
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884838119093Telemetry AccessoriesECG 5 lead Grabber, IEC, Tele9898031719312026-05-26
00884838119109Telemetry AccessoriesECG 5 lead Grabber, IEC + SpO2, Tele9898031719512026-05-26
00884838119116Telemetry AccessoriesECG 6 lead Grabber, IEC, Tele9898031719612026-05-26
00884838119123Telemetry AccessoriesECG 6 lead Grabber, IEC + SpO2, Tele9898031719712026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944413812475Ultrasound Transducer Edan Instruments, Inc.HGL2025-11-04
06944413812482Ultrasound Transducer Edan Instruments, Inc.HGL2025-11-04
06944413812505Fetal & Maternal ModuleEdan Instruments, Inc.HGL2025-11-04
06944413812512Ultrasound Transducer Edan Instruments, Inc.HGL2025-11-04
06944413812529Ultrasound Transducer Edan Instruments, Inc.HGL2025-11-04
06944413812543Fetal & Maternal ModuleEdan Instruments, Inc.HGL2025-11-04
00857901006392UTASL K C TECHNOLOGIES, INC.HGL2022-02-04
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHHGL2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHHGL2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHHGL2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHHGL2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHHGL2021-03-08
05051968041265DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDHGL2020-02-17
05051968041272DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDHGL2020-02-17
06944413807242US TransducerEdan Instruments, Inc.HGL2018-10-19
00884838034242Avalon CL Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHHGL2016-10-19
00884838021488Avalon Ultrasound Transducer USAPhilips Medizin Systeme Böblingen GmbHHGL2016-10-03
M745FM10835AIVAMERICAN IV PRODUCTS, INC.HGL2016-09-24
008167870233052.10MHZ OB PROBEPARKS MEDICAL ELECTRONICS, INC.HGL2016-09-24
008167870233122.10MHZ OB PROBE 641-APARKS MEDICAL ELECTRONICS, INC.HGL2016-09-24
008167870233292.15MHZ OB PROBEPARKS MEDICAL ELECTRONICS, INC.HGL2016-09-24
008167870233362.15MHZ OB PROBE 641-APARKS MEDICAL ELECTRONICS, INC.HGL2016-09-24
008167870233432.20MHZ OB PROBEPARKS MEDICAL ELECTRONICS, INC.HGL2016-09-24
008167870233502.20MHZ OB PROBE 641-APARKS MEDICAL ELECTRONICS, INC.HGL2016-09-24
008167870233672.25MHZ OB PROBEPARKS MEDICAL ELECTRONICS, INC.HGL2016-09-24
008167870233742.25MHZ OB PROBE 641-APARKS MEDICAL ELECTRONICS, INC.HGL2016-09-24
008167870233812.30MHZ OB PROBEPARKS MEDICAL ELECTRONICS, INC.HGL2016-09-24
008167870233982.75 MHZ OB PROBEPARKS MEDICAL ELECTRONICS, INC.HGL2016-09-24
008167870234112.00MHZ OB PROBE 641PARKS MEDICAL ELECTRONICS, INC.HGL2016-09-24
008167870234282.10MHZ OB PROBE 641PARKS MEDICAL ELECTRONICS, INC.HGL2016-09-24