e.p.t. Early Pregnancy test

GUDID 00363736953034

e.p.t.® Analog 3 Ct

PRESTIGE BRANDS HOLDINGS, INC.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Primary Device ID00363736953034
NIH Device Record Keya6c30fbb-6ea8-4d06-8091-1271cd1581d3
Commercial Distribution StatusIn Commercial Distribution
Brand Namee.p.t. Early Pregnancy test
Version Model NumberEPT visual
Company DUNS159655021
Company NamePRESTIGE BRANDS HOLDINGS, INC.
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

Customer Support Contacts

Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx
Phone1-800-378-1783
Emailxx@xx.xx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures above 50⁰ C (120⁰ F). Store at room temp away from heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS100363736953034 [Primary]
GS100633472000225 [Unit of Use]
GS110363736953031 [Package]
Package: Shipping case [12 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [e.p.t. Early Pregnancy test]

00363736953034e.p.t.® Analog 3 Ct
00363736952020e.p.t.® Analog 2 Ct
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