Kroger Early Result Pregnancy Test

GUDID 00041260374852

PLPL Kroger DPS Early Result

KROGER CO., THE

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 00041260374852
• NIH Device Record Key: 2e094830-687e-4fa7-98cd-3b226b2d22a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kroger Early Result Pregnancy Test
• Version Model Number: PLPL
• Company DUNS: 006999528
• Company Name: KROGER CO., THE
• 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: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• Email: xx@xx.xx
• Phone: 800-632-6900
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00041260374852 [Primary]
GS1	00633472000126 [Unit of Use]
GS1	10041260374859 [Package]; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-07-06
• Device Publish Date: 2016-06-30

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• 10041260020800 - Kroger: 2024-04-23 First Aid Kit, First Aid, Essentials, 160 items including 1 carrying case: 5 – Sheer Extra Large Bandages 2 IN x 4 IN (4.8 cm
• 10041260020565 - Crayola: 2024-01-12 Antibacterial Crayola Shaped Bandages, all one size, assorted colors, 0.75 IN x 2.8 IN (19 mm x 71 mm)
• 10011110381030 - Kroger: 2023-11-13 KROGER 9 SECOND FLEXIBLE TIP DIGITAL THERMOMETER DUAL SCALE
• 10041260245173 - Kroger: 2023-11-13 KROGERS COMFORTS FOR BABY FIREFLY 20 SEC FLEX THERMOMETER
• 10041260384322 - Kroger: 2023-09-21 Waterproof Transparent Dressing, all one size, 2.36 IN x 2.75 IN
• 00011110375759 - Kroger One Step Pregnancy Test: 2023-07-06 FPPL Kroger SPS +/-