Easy@Home Pregnancy Test (3 HCG Midstreams) EZM1-H3

GUDID 10855944007243

Easy@Home 3 Pregnancy Test Sticks

EASY HEALTHCARE CORPORATION

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10855944007243
NIH Device Record Key24b4161e-92d2-4ac0-b5e7-31c9c3d0679c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Pregnancy Test (3 HCG Midstreams)
Version Model NumberEZW1-M
Catalog NumberEZM1-H3
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100855944007246 [Primary]
GS110855944007243 [Package]
Contains: 00855944007246
Package: Carton [84 Units]
In Commercial Distribution
GS120855944007240 [Package]
Contains: 00855944007246
Package: Carton [70 Units]
In Commercial Distribution
GS130855944007247 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-01
Device Publish Date2018-07-01

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