Fetal & maternal monitor

GUDID 06944413800441

Edan Instruments, Inc.

Foetal cardiac monitor
Primary Device ID06944413800441
NIH Device Record Key55d0fe87-6b7f-4a2e-816c-b905152d2c21
Commercial Distribution StatusIn Commercial Distribution
Brand NameFetal & maternal monitor
Version Model NumberF9 Express
Company DUNS529173163
Company NameEdan Instruments, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS106944413800441 [Primary]

FDA Product Code

HGGController, Abortion Unit, Vacuum

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-01

On-Brand Devices [Fetal & maternal monitor]

06944413806856FM-9000 Plus
06944413806849FM-9000
06944413806832FM-6000
06944413800465F6 Express
06944413800458F6
06944413800441F9 Express
06944413800434F9

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