[email protected] Fingertip Pulse Oximeter

GUDID 10810038630004

EASY HEALTHCARE CORPORATION

Pulse oximeter, battery-powered
Primary Device ID10810038630004
NIH Device Record Key296a22c6-a4e7-43e7-ae1c-cfaa09141182
Commercial Distribution StatusIn Commercial Distribution
Brand Name[email protected] Fingertip Pulse Oximeter
Version Model NumberEHP035
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
GS100810038630007 [Primary]
GS110810038630004 [Package]
Contains: 00810038630007
Package: Carton [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [[email protected] Fingertip Pulse Oximeter]

00850253007116EHP50D1
00850003180199EHP50D1
10810038630004EHP035

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