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

Devices Manufactured by KROGER CO., THE

• 60041260025749 - Kroger: 2025-08-13 Antibacterial Non-Stick Pads, all one size, 3 IN x 4 IN (7.6 cm x 10.1 cm). Contains: Polyhexamethylene Biguadine (PHMB) 0.2%
• 20011110338239 - Kroger Pen Needles: 2025-07-24 Sterile, single-use, 6-bevel pen needles, 31 Gauge, 8mm (5/16") Length
• 10041260003599 - Kroger Pen Needles: 2025-07-24 Sterile, single-use, 6-bevel pen needles, 31 gauge, 6mm (1/4") length, extra-thin wall
• 10041260003605 - Kroger Pen Needles: 2025-07-24 Sterile, single-use, 6-bevel pen needles, 31 Gauge, 8mm (5/16") Length, extra-thin wall
• 20041260343463 - Kroger Pen Needles: 2025-07-24 Sterile, single-use, 6-bevel pen needles, 31 Gauge, 6mm (1/4") Length
• 10041260364621 - Kroger Pen Needles: 2025-07-24 Sterile, single-use, 6-bevel pen needles, 32 Gauge, 4mm (5/32") Length
• 30041260346966 - Kroger Blood Glucose Test Strips: 2025-07-24 Test Strips, Kroger, 25CT
• 10041260346986 - Kroger Blood Glucose Test Strips: 2025-07-24 Test Strips, Kroger, 50CT, 100CT