Areta Fingertip Pulse Oximeter

GUDID 00850253007109

EASY HEALTHCARE CORPORATION

Telemetric pulse oximeter
Primary Device ID00850253007109
NIH Device Record Key87518235-cf96-4483-89de-1125893c95b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAreta Fingertip Pulse Oximeter
Version Model NumberEZD-500A
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850253007109 [Primary]
GS110850253007106 [Package]
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-26
Device Publish Date2016-08-01

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