Premom Pregnancy Test Strips (30 Tests) PMS-130

GUDID 10810038632527

Premom Pregnancy Test Strips (30 test per kit)

EASY HEALTHCARE CORPORATION

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10810038632527
NIH Device Record Keya95353dd-dd4f-49d5-9ffc-7ec34b537077
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremom Pregnancy Test Strips (30 Tests)
Version Model NumberPM1-S
Catalog NumberPMS-130
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count30
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
GS100810038632520 [Primary]
GS110810038632527 [Package]
Contains: 00810038632520
Package: Carton [120 Units]
In Commercial Distribution
GS130810038632521 [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 Date2022-02-25
Device Publish Date2022-02-17

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