GUDID 06944413805590

Edan Instruments, Inc.

Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe
Primary Device ID06944413805590
NIH Device Record Key3bc2f7fd-1c22-4bed-8b09-2e6a608e3c37
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3MHz
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413805590 [Primary]

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

Devices Manufactured by Edan Instruments, Inc.

06944413820463 - Holter ECG and ABP System2023-12-08
06944413820470 - Holter ECG and ABP System2023-12-08
06944413820487 - Holter ECG and ABP System2023-12-08
06944413820494 - Holter ECG and ABP System2023-12-08
06944413820500 - Holter ECG and ABP System2023-12-08
06944413820562 - Electrocardiograph2023-12-08
06944413820616 - Electrocardiograph2023-12-08
06944413812680 - Ambulatory Blood Pressure Monitor2023-06-29
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