Shop Rite Early Result Pregnancy Test

GUDID 00041190222650

Shop Rite SPS Early Result Bonus

WAKEFERN FOOD CORP.

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

• Primary Device ID: 00041190222650
• NIH Device Record Key: a8cddc4c-b0f0-49cd-8e65-1d2a7a8d360d
• Commercial Distribution Discontinuation: 2019-03-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Shop Rite Early Result Pregnancy Test
• Version Model Number: PLPL
• Company DUNS: 006972418
• Company Name: WAKEFERN FOOD CORP.
• 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: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• 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	00041190222650 [Primary]
GS1	00633472000126 [Unit of Use]
GS1	10041190222657 [Package]; Package: Shipping case [24 Units]; Discontinued: 2019-03-04; Not 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: 5
• Public Version Date: 2023-07-06
• Device Publish Date: 2016-06-30

Devices Manufactured by WAKEFERN FOOD CORP.

• 00041190216697 - Shop Rite Pregnancy Test: 2023-07-06 FPPL Shop Rite DPS +/-
• 00041190222650 - Shop Rite Early Result Pregnancy Test: 2023-07-06Shop Rite SPS Early Result Bonus
• 00041190222650 - Shop Rite Early Result Pregnancy Test: 2023-07-06 Shop Rite SPS Early Result Bonus
• 10041190215352 - Shop Rite: 2022-06-10
• 10041190227867 - Shop Rite Tampons: 2019-12-09
• 10041190227874 - Shop Rite Tampons: 2019-12-09
• 10041190227881 - Shop Rite Tampons: 2019-12-09