Equate

GUDID 00681131157940

Walmart Equate DPS Digital Early Result

WAL-MART STORES, INC.

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

• Primary Device ID: 00681131157940
• NIH Device Record Key: a8fc761c-5b37-478b-81cd-8fc67ba9be8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equate
• Version Model Number: Digital Pregnancy Test
• Company DUNS: 051957769
• Company Name: WAL-MART STORES, INC.
• 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: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• Email: xx@xx.xx
• Phone: 1-888-287-1915
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00633472000041 [Unit of Use]
GS1	00681131157940 [Primary]
GS1	10681131157947 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-23

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• 20681131286255: Kinesiology Tape Black, 1 roll - 2 IN x 5.4 YDS (50 mm x 5 m) with 20 black pre-cut strips all
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• 20681131286224: Flexible Fabric Bandages Antibacterial, all one size, 3/4 IN x 3 IN (19 mm x 76 mm)
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