Ultrasonic Pocket Doppler

GUDID 06944413801813

Edan Instruments, Inc.

Foetal Doppler system
Primary Device ID06944413801813
NIH Device Record Key39072266-919e-44ab-a822-2345e53eaa23
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasonic Pocket Doppler
Version Model NumberSD3 PRO
Company DUNS529173163
Company NameEdan Instruments, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413801813 [Primary]
GS16944413802506 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNGMonitor, Ultrasonic, Fetal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

On-Brand Devices [Ultrasonic Pocket Doppler]

06944413808751SD1
06944413806795PD-1000 Plus
06944413806788PD-1000
06944413806771PD-100 Pro
06944413806764PD-100 Plus
06944413806757PD-1000 Pro
06944413806740PD-100B
06944413806733PD-100A
06944413802032SD3 Vascular
06944413801813SD3 PRO
06944413801806SD3 PLUS
06944413801790SD3 LITE
06944413801783SD3
06944413800564SONOTRAX Vascular
06944413800175SONOTRAX Ⅱ Pro
06944413800168SONOTRAX Ⅱ
06944413800151SONOTRAX Pro
06944413800144SONOTRAX Basic A
06944413800137SONOTRAX Basic
06944413800120SONOTRAX Lite

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