HyVee Health

GUDID 00075450259339

FPPL Hy-Vee DPS +/- (ER)

HY-VEE, INC.

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: 00075450259339
• NIH Device Record Key: ca4f9ad2-36e8-427a-9ce6-9251c909c388
• Commercial Distribution Discontinuation: 2019-07-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HyVee Health
• Version Model Number: One Step Pregnancy Test
• Company DUNS: 006925671
• Company Name: HY-VEE, INC.
• 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: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• Email: xx@xx.xx
• Phone: 800-289-8343
• 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	00075450259339 [Primary]
GS1	00633472000133 [Unit of Use]
GS1	10075450259336 [Package]; Package: Shipping Case [24 Units]; Discontinued: 2019-07-22; 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: 4
• Public Version Date: 2019-07-23
• Device Publish Date: 2016-09-21

On-Brand Devices [HyVee Health ]

• 10075450290803: FPPL Hy-Vee SPS +/- (ER)
• 00075450259339: FPPL Hy-Vee DPS +/- (ER)
• 00075450123777: Hy-Vee DPS Early Result