Dollar General

GUDID 10751774260479

Dollar General DPS +/-

DOLGENCORP, LLC

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 10751774260479
• NIH Device Record Key: 33789ac1-ce5f-4fb0-a83f-b70b0d874568
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dollar General
• Version Model Number: One Step Pregnancy Test
• Company DUNS: 068331990
• Company Name: DOLGENCORP, LLC
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00633472000133 [Unit of Use]
GS1	00751774260472 [Primary]
GS1	10751774260479 [Package]; Contains: 00751774260472; Package: Shipping case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012215

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: 2025-05-19
• Device Publish Date: 2025-05-09

Devices Manufactured by DOLGENCORP, LLC

• 10751774260479 - Dollar General: 2025-05-19Dollar General DPS +/-
• 10751774260479 - Dollar General: 2025-05-19 Dollar General DPS +/-
• 10751774262466 - DG Health: 2025-05-19 Dollar General SPS +/-
• 00646011887409 - Rexall Sterile Saline Wound Wash: 2024-10-14 Sterile Saline Wound Wash
• 10197344110056 - Rexall: 2024-08-16 GLOVE,EXAM,NITRIL,PF,30CT,OSFM,DG
• 10751774250784 - DG health: 2023-11-06 DOLLAR GENERAL 5D ONE STEP PREG CASSETTE
• 00095072049552 - DG Health: 2023-09-26 DGH Multi-purpose solution Green 12 oz
• 00095072100048 - DG Health: 2023-09-26 DGH Advanced Multi-purpose solution 4 oz
• 00850039396014 - Rexall: 2023-09-08 Rexall DGH Denture Adhesive Cream - Super Hold