H.E.B

GUDID 10041220575791

HEB DPS Advanced Early Result Pink Cap

H. E. BUTT GROCERY COMPANY

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid 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 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 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 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: 10041220575791
• NIH Device Record Key: 4b37a15d-2195-480b-af7f-89a56d1c7bd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H.E.B
• Version Model Number: Advanced Early Result Pregnancy Test
• Company DUNS: 007924756
• Company Name: H. E. BUTT GROCERY COMPANY
• 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: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• 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
• 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
• 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
• 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
• 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	00041220575794 [Primary]
GS1	00633472000508 [Unit of Use]
GS1	10041220575791 [Package]; Contains: 00041220575794; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-21
• Device Publish Date: 2021-06-13

On-Brand Devices [H.E.B ]

• 00041220103140: FPPL HEB WIP SPS +/-
• 00041220961689: CB8 Digital Pregnancy Stick HEB DPS Digital Early US
• 00041220191390: PLPL HEB DPS EARLY
• 80041220901735: Flosser, Center Pick, Mint
• 80041220817975: Flosser, Center Pick, Mint
• 80041220817968: Flosser, Center pick, unflavored
• 00041220384440: Power Toothbrush, Polaris, Medium
• 80041220384439: Power Toothbrush, Polaris, Medium
• 80041220384422: Power Toothbrush, Polaris, Soft
• 00041220175505: Power Toothbrush, Polaris, soft
• 80041220074941: Floss, Intense Clean Icy Mint, 40M
• 80041220074910: Floss, Extra Comfort, Mint, 40M
• 00041220074891: Floss, Extra Comfort, Mint, 40M
• 00041220074778: Floss, Super Slip, Mint, 50M
• 00041220910045: PLPL HEB DPS BILINGUAL EARLY
• 00041220103164: WWOT HEB Ovulation
• 10041220723475: HEB 5ct Advanced +/-
• 10041220575791: HEB DPS Advanced Early Result Pink Cap
• 10041220575760: HEB DPS Advanced +/-
• 10041220569318: HEB SPS Advanced +/-
• 10041220524546: HEB Ovulation 10+1
• 10041220646477: HEB One Step Pregnancy Cassette
• 10041220575777: HEB SPS Advanced Early Result Pink Cap
• 10041220524560: HEB DPS Digital Early Result Blue Cap
• 10041220524553: A convenience kit consisting of 1 Digital Pregnancy Test and 1 Early Result Pregnancy Test
• 00041220558032: FPPL HEB SPS +/-
• 10041220558022: PLPL HEB DPS Bilingual Early Result 2ct
• 00041220524426: H.E.B One Step Ovulation Predictor
• 10041220558046: PLPL HEB DPS Early Result Pink Cap
• 10041220524447: CB8 HEB DPS Digital Early 2ct
• 00041220524433: FPPL HEB DPS +/-
• 00041220103157: FPPL HEB DPS +/-
• 10041220549754: HEB 5D CASSETTE