Dx12 exercise ECG Cable

GUDID 06944413803282

Edan Instruments, Inc.

Electrocardiographic lead set, reusable
Primary Device ID06944413803282
NIH Device Record Key73d695d1-9539-4552-b60a-90d6d5d77343
Commercial Distribution StatusIn Commercial Distribution
Brand NameDx12 exercise ECG Cable
Version Model Number12-Lead, snap, IEC, reusable
Company DUNS529173163
Company NameEdan Instruments, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413803282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSACable, Transducer And Electrode, Patient, (Including Connector)

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 [Dx12 exercise ECG Cable]

0694441380329912-Lead, snap, AHA, reusable
0694441380328212-Lead, snap, IEC, reusable

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