FDA.reportPublic FDA data

Ultrasound Transducer

Primary DI
06944413812512
Brand
Ultrasound Transducer
Company
Edan Instruments, Inc.
Model
US-SAF
Published
2025-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K241882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241882000Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.2025-08-27HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944413812512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944413812512069444138125126944413812512

GMDN Terms#

Term, Definition table
TermDefinition
Foetal Doppler system probeA hand-operated component of a foetal Doppler system intended to be 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.

Regulatory Flags#

DUNS number
529173163
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944413817210Connection Cable01.57.4721782026-05-19
06944413817234 Connection Cable01.57.4722162026-05-19
06944413820050EMG/Stimulation sensor01.57.4726242026-05-19
06944413820074EMG/Stimulation sensor01.57.4726312026-05-19
06944413825475Connection Cable01.57.4722812026-05-19
06944413825482Connection Cable01.57.4723812026-05-19
06944413834026EMG/Stimulation sensor01.57.4726252026-05-19
06944413834736EMG/Stimulation sensor01.57.472623 2026-05-19
06944413866133Stimulation SystemPR362026-05-15
06944413866140Stimulation SystemPR382026-05-15
06944413866157Stimulation SystemPR4 Pro2026-05-15
06944413866164Stimulation SystemPR42026-05-15
06944413866171Stimulation SystemPA362026-05-15
06944413866188Stimulation SystemPA382026-05-15
06944413866195Stimulation SystemPA4 Pro2026-05-15
06944413866201Stimulation SystemPA42026-05-15
06944413866218Stimulation SystemQ32026-05-15
06944413866225Stimulation SystemQ92026-05-15
06944413866232Stimulation SystemQ102026-05-15
06944413866249Stimulation SystemQ122026-05-15

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
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
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