FDA.reportPublic FDA data

DOPPLEX

Primary DI
05051968041272
Brand
DOPPLEX
Company
HUNTLEIGH HEALTHCARE LIMITED
Model
OP3XS-USA
Catalog number
OP3XS-USA
Device description
HIGH SENSITIVITY 3MHZ OBSTETRIC PROBE
Published
2020-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K183574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183574000SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesHuntleigh Healthcare , Ltd.2019-09-06DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051968041272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051968041272050519680412725051968041272

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
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure700 millibar1060 millibar
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Humidity5 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature-25 Degrees Celsius5 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4402920485885sales@huntleigh-diagnostics.co.uk

Regulatory Flags#

DUNS number
217207083
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051968014030DOPPLEXACC7ACC7 2016-09-19
05051968032713SONICAIDACC-MI1136ACC-MI1136 2016-09-19
05051968019172DOPPLEXFD1+-PFD1+-P-USA2016-08-22
05051968048233SONICAIDTEAM3A-B3-USATEAM3A-B3-USA2025-12-10
05051968048240SONICAIDTEAM3A-MB3-USATEAM3A-MB3-USA2025-12-10
05051968048257SONICAIDTEAM3A-NB3-USATEAM3A-NB3-USA2025-12-10
05051968048264SONICAIDTEAM3A-NMB3-USATEAM3A-NMB3-USA2025-12-10
05051968048271SONICAIDTEAM3A-NZB3-USATEAM3A-NZB3-USA2025-12-10
05051968048288SONICAIDTEAM3A-ZB3-USATEAM3A-ZB3-USA2025-12-10
05051968048295OBIXOBIX_A3OBIX_A32025-12-10
05051968048301OBIXOBIX_A3_BOBIX_A3_B2025-12-10
05051968048318OBIXOBIX_AN3_BOBIX_AN3_B2025-12-10
05051968048325OBIXOBIX_ANM3OBIX_ANM32025-12-10
05051968048332OBIXOBIX_ANM3_BOBIX_ANM3_B2025-12-10
05051968048349OBIXOBIX_AN3_ZOBIX_AN3_Z2025-12-10
05051968048356OBIXOBIX_AN3_Z_BOBIX_AN3_Z_B2025-12-10
05051968048363OBIXOBIX_INM3-BIOOBIX_INM3-BIO2025-12-10
05051968048370OBIXOBIX_INM3B-BIOOBIX_INM3B-BIO2025-12-10
05051968048387OBIXOBIX_INM3OBIX_INM32025-12-10
05051968048394OBIXOBIX_INM3_BOBIX_INM3_B2025-12-10

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
06944413807242US TransducerEdan Instruments, Inc.HGL2018-10-19
00884838034242Avalon CL Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHHGL2016-10-19
00884838002722Avalon US TransducerPhilips Medizin Systeme Böblingen GmbHHGL2016-10-03
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