HyVee Health

GUDID 00075450259339

FPPL Hy-Vee DPS +/- (ER)

HY-VEE, INC.

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

• 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