Walgreens

GUDID 10311917211227

Early Result Pregnancy Test - 2 Tests with Insert

WALGREEN CO.

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

• Primary Device ID: 10311917211227
• NIH Device Record Key: b0a4b6b1-1541-40b0-b9b7-bd6cfd58b8dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Walgreens
• Version Model Number: MidStream 6
• 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: 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

Device Dimensions

• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter
• Height: 142.1 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00311917211220 [Primary]
GS1	00748349000540 [Unit of Use]
GS1	10311917211227 [Package]; Contains: 00311917211220; Package: Shipping Case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921099

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: 2020-02-17
• Device Publish Date: 2020-02-07

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