iT20 SpO2 extension cable

GUDID 06944413807075

Edan Instruments, Inc.

Electrical-only medical device connection cable, reusable
Primary Device ID06944413807075
NIH Device Record Key17ef6f64-d919-43d4-870a-1845bb0638ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameiT20 SpO2 extension cable
Version Model NumberiT20 SpO2 extension cable, 0.65m
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
GS106944413807075 [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 Date2017-02-22

Devices Manufactured by Edan Instruments, Inc.

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06944413813984 - ECG cable2024-06-06
06944413813991 - ECG cable2024-06-06
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06944413814011 - ECG cable2024-06-06

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