e.p.t. Digital Early Pregnancy Test

GUDID 10363736992023

e.p.t.® Digital 2 Ct

PRESTIGE BRANDS HOLDINGS, INC.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10363736992023
• NIH Device Record Key: 94fcab20-fe37-4010-853e-e44e66a5fc1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e.p.t. Digital Early Pregnancy Test
• Version Model Number: EPT Digital
• Company DUNS: 159655021
• Company Name: PRESTIGE BRANDS HOLDINGS, INC.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx
• Phone: 1-800-378-1783
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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 Agency	Device ID
GS1	00363736992026 [Primary]
GS1	00633472000232 [Unit of Use]
GS1	10363736992023 [Package]; Contains: 00363736992026; Package: Shipping case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061769

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

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

• 10363736993037: e.p.t.® Digital 3 Ct
• 10363736992023: e.p.t.® Digital 2 Ct