FDA.reportPublic FDA data

NA

Primary DI
06944413805569
Brand
NA
Company
Edan Instruments, Inc.
Model
5.0MHz
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HEPMonitor, Blood-Flow, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEPMonitor, Blood-Flow, UltrasonicObstetrics/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
06944413805569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944413805569069444138055696944413805569

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system probeA hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944413805323SpO2 SensorSpO2 Finger Sensor, adult, 1m, reusable2016-09-01
06944413805361SpO2 SensorSH4 Adult Silicone Soft-tip2016-09-01
06944413805385SpO2 SensorSH5 pediatric Silicone Soft-tip2016-09-01
06944413805422SpO2 SensorSHD-P, pediatric, disposable2016-09-01
06944413805439SpO2 SensorSHD-A , adult, disposable2016-09-01
06944413807075iT20 SpO2 extension cableiT20 SpO2 extension cable, 0.65m2017-02-22
06944413809468Connection Cable01.13.0374772026-10-15
06944413835153Telemetry MonitoriT302026-08-26
06944413835214Telemetry MonitoriT502026-08-26
06944413844919SE-1202 Series ElectrocardiographSE-1202E2026-07-21
06944413847422SE-1202 Series ElectrocardiographSE-12022026-07-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B632MDB01009MedibluMEDIBLU MEDICAL LLCHEP2020-06-25
B510PD1000PRO1ADVANCED POCKET DOPPLERADVANCED INSTRUMENTATIONS, INC.HEP2020-04-17
B510PD100PRO1ADVANCED POCKET DOPPLERADVANCED INSTRUMENTATIONS, INC.HEP2020-04-17
GYNXD12500Sonotrax Pro Fetal DopplerGYNEX CORPORATIONHEP2017-01-19
GYNXDB12450Sonotrax Basic Fetal DopplerGYNEX CORPORATIONHEP2017-01-19
40612479199628McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199635McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199642McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199710McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199727McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199734McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
00888937010312MediChoiceCoopersurgical, Inc.HEP2016-09-23
00815871020367E-STAvanteHEP2016-09-23
00815871020374E-STAvanteHEP2016-09-23
00815871020381E-STAvanteHEP2016-09-23
00815871020398E-STAvanteHEP2016-09-23
00815871020404E-STAvanteHEP2016-09-23
00815871020411E-STAvanteHEP2016-09-23
00815871020428E-STAvanteHEP2016-09-23
00815871021494E-ST ProAvanteHEP2016-09-23
00382830028011NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-23
00382830028004NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-21
00382830028172NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-21
00382830028189NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-21
00382830028288NATUS NEUROLOGY NATUS NEUROLOGY INCORPORATEDHEP2016-09-15
00382830028295NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-15
00382830028301NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-15
00888937010299MediChoiceCoopersurgical, Inc.HEP2016-09-14
00888937010305MediChoiceCoopersurgical, Inc.HEP2016-09-14
06944413800120Ultrasonic Pocket DopplerEdan Instruments, Inc.HEP2016-09-01