PC ECG

GUDID 06944413800533

Edan Instruments, Inc.

Electrocardiograph, professional, multichannel
Primary Device ID06944413800533
NIH Device Record Key51480a1f-d450-4dfb-808b-2af8f0b223df
Commercial Distribution StatusIn Commercial Distribution
Brand NamePC ECG
Version Model NumberSE-1010
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
GS106944413800533 [Primary]
GS16944413807174 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-01

On-Brand Devices [PC ECG]

06944413807778ECG-1212
06944413806948ECG-1212/ST
06944413802759PADECG
06944413802049SE-1515
06944413800533SE-1010

Trademark Results [PC ECG]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PC ECG
PC ECG
78322450 not registered Dead/Abandoned
BTS Holdings
2003-11-03

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