GUDID 06944413803664

Edan Instruments, Inc.

Electrocardiographic lead set, reusable
Primary Device ID06944413803664
NIH Device Record Keyc7b3135b-1f2b-4ce6-b343-1ad70e1be3fd
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberHolter USB Cable
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413803664 [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

Devices Manufactured by Edan Instruments, Inc.

06944413815889 - Patient Monitor2024-06-25
06944413815896 - Patient Monitor2024-06-25
06944413815902 - Patient Monitor2024-06-25
06944413813977 - ECG cable2024-06-06
06944413813984 - ECG cable2024-06-06
06944413813991 - ECG cable2024-06-06
06944413814004 - ECG cable2024-06-06
06944413814011 - ECG cable2024-06-06

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