Health Mart

GUDID 10052569143817

Health Mart DPS +/- Blue Cap

MCKESSON CORPORATION

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 (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 ID: 10052569143817
• NIH Device Record Key: 42103df9-268f-49c0-bf50-2cdc6ae7b2e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Mart
• Version Model Number: One Step Pregnancy Test
• Company DUNS: 177667227
• Company Name: MCKESSON CORPORATION
• 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: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00052569143810 [Primary]
GS1	00633472000133 [Unit of Use]
GS1	10052569143817 [Package]; Contains: 00052569143810; Package: Shipping case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042280

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-06
• Device Publish Date: 2020-09-28

On-Brand Devices [Health Mart ]

• 10052569136543: BP3NU1-3E
• 10052569136536: BP3MV1-3EHM
• 10052569136529: BP3MU1-2EHM
• 10052569136512: BP3MR1-HHM
• 10052569136505: BP3BR1-1HM
• 40052569134816: A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use t
• 40052569134793: A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use t
• 40052569134786: A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use t
• 40052569134779: 50 pack of probe covers. A device intended to be used as a physical barrier between the patient
• 40052569134762: A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use t
• 40052569134754: A hand-held, battery-powered, electronic instrument designed to measure a patient's body tempera
• 00052569134757: A hand-held, battery-powered, electronic instrument designed to measure a patient's body tempera
• 10052569143817: Health Mart DPS +/- Blue Cap