Easy@Home Digital Basal Thermometer

GUDID 10810038630189

EASY HEALTHCARE CORPORATION

Natural conception assistance kit
Primary Device ID10810038630189
NIH Device Record Key4348d00b-ae3d-40ad-b16a-23ad696ad371
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Digital Basal Thermometer
Version Model NumberEBT-100
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100810038630182 [Primary]
GS110810038630189 [Package]
Contains: 00810038630182
Package: Carton [200 Units]
In Commercial Distribution
GS120810038630186 [Package]
Contains: 00810038630182
Package: Carton [160 Units]
In Commercial Distribution
GS130810038630183 [Package]
Contains: 00810038630182
Package: [240 Units]
In Commercial Distribution
GS140810038630180 [Package]
Contains: 00810038630182
Package: [120 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

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 [Easy@Home Digital Basal Thermometer]

10810038630189EBT-100
10850003180035EBT100
10810038631605EBT-100 PURPLE
10810038632534EBT-018
00810038633213EBT-018 PINK
00810038632698EBT-018 PURPLE

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