Exercise ECG Cable

GUDID 06944413803787

Edan Instruments, Inc.

Electrocardiographic lead set, reusable
Primary Device ID06944413803787
NIH Device Record Key6f870dc6-5429-4d6a-8608-6027b7cbe29d
Commercial Distribution StatusIn Commercial Distribution
Brand NameExercise 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
GS106944413803787 [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 [Exercise ECG Cable]

0694441380378712-Lead, snap, IEC, reusable
0694441380377012-Lead, snap,AHA, reusable
0694441380354112-Lead, snap,AHA, reusable
0694441380353412-Lead, snap, IEC, reusable

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