Well at Walgreens 3056

GUDID 00311917169835

The Walgreens At-Home A1C Test Kit provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.

WALGREEN CO.

Glycated haemoglobin (HbA1c) monitoring system IVD, home-use

• Primary Device ID: 00311917169835
• NIH Device Record Key: 3242203b-2f5f-44f8-9f72-9b996a1d7937
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Well at Walgreens
• Version Model Number: 3056
• Catalog Number: 3056
• 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: true
• 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: 1-800-925-4733
• Email: consumerrelations.pq@walgreens.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00311917169835 [Primary]
GS1	10311917169832 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090413

FDA Product Code

• LCP: Assay, Glycosylated Hemoglobin

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: 2016-08-15

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