Winco Foods

GUDID 10070552250960

Winco SPS +/- Blue Cap

WINCO FOODS, LLC

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

• 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