FDA.reportPublic FDA data

TOCO Transducer

Primary DI
06944413805507
Brand
TOCO Transducer
Company
Edan Instruments, Inc.
Model
Blue label
Published
2016-09-01
Public version status
Update
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
K150901000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150901000Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc.2015-07-01HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944413805507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944413805507069444138055076944413805507

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotocograph transducerA device that converts birthing contractions to electrical signals and is used together with cardiotocograph (CTG) which displays the signals. It is a dedicated transducer (a tocodynamometer) that is usually strapped onto the womans abdomen. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529173163
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
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
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
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