Walgreens

GUDID 00311917199368

Walgreens Digital Early Result Blue Cap

WALGREEN CO.

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

• Primary Device ID: 00311917199368
• NIH Device Record Key: 56ba29fc-4f75-48de-9c0a-30383ddb9680
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Walgreens
• Version Model Number: Digital Pregnancy Test
• Company DUNS: 008965063
• Company Name: WALGREEN CO.
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-899-7353
• Email: consumerrelations.pq@walgreens.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00311917199368 [Primary]
GS1	00633472000041 [Unit of Use]
GS1	10311917199365 [Package]; Package: Shipping case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060128

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: 2019-01-07
• Device Publish Date: 2018-12-05

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