H.E.B

GUDID 00041220558032

FPPL HEB SPS +/-

H. E. BUTT GROCERY COMPANY

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

• Primary Device ID: 00041220558032
• NIH Device Record Key: 1c05d724-d1c1-494a-a891-3ba58d33d020
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H.E.B
• Version Model Number: Analog One Step Pregnancy Test
• Company DUNS: 007924756
• Company Name: H. E. BUTT GROCERY COMPANY
• Device Count: 1
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00041220558032 [Primary]
GS1	10041220558039 [Package]; Package: Shipping case [24 Units]; Discontinued: 2021-10-20; 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: 2
• Public Version Date: 2021-10-22
• Device Publish Date: 2019-02-06

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