Holter ECG Cable

GUDID 06944413803626

Edan Instruments, Inc.

Electrocardiographic lead set, reusable
Primary Device ID06944413803626
NIH Device Record Keybccf70b2-959f-4874-9a67-d024cfbc5f92
Commercial Distribution StatusIn Commercial Distribution
Brand NameHolter ECG Cable
Version Model Number3-Lead, snap stye, 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
GS106944413803626 [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 [Holter ECG Cable]

0694441380390912-Lead, snap stye, IEC, reusable
069444138036573-Lead, snap stye, AHA, reusable
069444138036403-Lead, snap stye, IEC, reusable
069444138036333-Lead, snap stye, AHA, reusable
069444138036263-Lead, snap stye, IEC, reusable
0694441380361912-Lead, snap stye, AHA, reusable

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