e.p.t. Early Pregnancy Test

GUDID 00363736952020

e.p.t.® Analog 2 Ct

PRESTIGE BRANDS HOLDINGS, INC.

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

• Primary Device ID: 00363736952020
• NIH Device Record Key: 27005db1-2d61-47a1-9032-8028f3f3821d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e.p.t. Early Pregnancy Test
• Version Model Number: EPT visual
• 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 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 - 30⁰ C (36 - 86⁰ F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00363736952020 [Primary]
GS1	00633472000225 [Unit of Use]
GS1	10363736952027 [Package]; Package: shipping case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040329

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: 2016-09-20

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

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