Winco Foods

GUDID 10070552250960

Winco SPS +/- Blue Cap

WINCO FOODS, LLC

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

• Primary Device ID: 10070552250960
• NIH Device Record Key: afecf88c-0b6a-49fb-8167-1037aad524ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Winco Foods
• Version Model Number: One Step Pregnancy Test
• Company DUNS: 056098817
• Company Name: WINCO FOODS, LLC
• 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: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• Email: xx@xx.xx
• Phone: 800-824-1706
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00070552250963 [Primary]
GS1	10070552250960 [Package]; Contains: 00070552250963; Package: Shipping case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042280

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: 2020-02-05
• Device Publish Date: 2020-01-28

Devices Manufactured by WINCO FOODS, LLC

• 10070552251042 - WinCo: 2022-06-15 Compact First Aid Kit
• 10070552250960 - Winco Foods: 2020-02-05Winco SPS +/- Blue Cap
• 10070552250960 - Winco Foods: 2020-02-05 Winco SPS +/- Blue Cap
• 10070552250076 - WINCO Tampons: 2019-12-09
• 10070552250083 - WINCO Tampons: 2019-12-09
• 10070552250090 - WINCO Tampons: 2019-12-09
• 10070552250106 - WINCO Tampons: 2019-12-09 Multi pack of 40 - 8 light/16 Regular/16 Super
• 10070552250120 - WINCO Tampons: 2019-12-09
• 10070552250137 - WINCO Tampons: 2019-12-09