DG health N/A

GUDID 10751774250784

DOLLAR GENERAL 5D ONE STEP PREG CASSETTE

DOLGENCORP, LLC

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

• Primary Device ID: 10751774250784
• NIH Device Record Key: 9494cfcf-9706-48b3-a2b8-0867a3df9bfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DG health
• Version Model Number: One Step Pregnancy Test
• Catalog Number: N/A
• Company DUNS: 068331990
• Company Name: DOLGENCORP, LLC
• Device Count: 1
• 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: false

Customer Support Contacts

• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00751774250787 [Primary]
GS1	10751774250784 [Package]; Contains: 00751774250787; Package: Shipping case [96 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210341

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: 2023-11-06
• Device Publish Date: 2023-10-27

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• 10834533001428: BDGSGR2
• 10834533001404: BDGGP36
• 10834533001398: Multipack of 36 tampons, 20 Regular, 8 Super and 8 Super plus absorbency
• 10834533001374: BDGGR36
• 10834533001015: BDGGS36
• 10834533000995: Multipack of 34 tampons, 17 Regular and 17 Super absorbency
• 10834533000988: BDGFS18
• 07290016625332: BDGFR18
• 00095072100048: DGH Advanced Multi-purpose solution 4 oz
• 00095072049552: DGH Multi-purpose solution Green 12 oz
• 10751774250784: DOLLAR GENERAL 5D ONE STEP PREG CASSETTE