Premom Pregnancy Test Midstream (3 Tests) PM1-M3-3

GUDID 10810038633265

Premom Pregnancy Test Midstream (3 Tests)

EASY HEALTHCARE CORPORATION

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10810038633265
NIH Device Record Key17e4a93e-b3f4-4387-ae55-81388286b418
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremom Pregnancy Test Midstream (3 Tests)
Version Model NumberPMS1-M
Catalog NumberPM1-M3-3
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 Kitfalse
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
GS100810038633268 [Primary]
GS110810038633265 [Package]
Contains: 00810038633268
Package: Carton [96 Units]
In Commercial Distribution
GS130810038633269 [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 Date2023-04-28
Device Publish Date2023-04-20

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