iT20 ECG cable

GUDID 06944413803695

Edan Instruments, Inc.

Electrocardiographic lead set, reusable
Primary Device ID06944413803695
NIH Device Record Key2598a5ad-3658-427e-b4f4-2d0d3e2cf350
Commercial Distribution StatusIn Commercial Distribution
Brand NameiT20 ECG cable
Version Model Number3-lead, clip,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
GS106944413803695 [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 Date2017-02-23

On-Brand Devices [iT20 ECG cable]

069444138037495-lead, clip,AHA, reusable
069444138037325-lead, clip,IEC, reusable
069444138037255-lead, snap,AHA, reusable
069444138037185-lead, snap,IEC, reusable
069444138037013-lead, clip,AHA, reusable
069444138036953-lead, clip,IEC, reusable
069444138036883-lead, snap,AHA reusable
069444138036713-lead, snap,IEC, reusable

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