Equate First Signal

GUDID 10681131175989

FHC-102H Walmart First Signal Preg Cassette

WAL-MART STORES, INC.

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

• Primary Device ID: 10681131175989
• NIH Device Record Key: 3ec5d14b-3bfd-4b00-9829-d0701627c30a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equate First Signal
• Version Model Number: One Step Pregnancy Test
• Company DUNS: 051957769
• Company Name: WAL-MART STORES, INC.
• 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: 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
• 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
• 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	00681131175982 [Primary]
GS1	10681131175989 [Package]; Contains: 00681131175982; Package: Shipping case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012215

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: 2018-10-29
• Device Publish Date: 2018-09-28

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