H.E.B

GUDID 10041220723475

HEB 5ct Advanced +/-

H. E. BUTT GROCERY COMPANY

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10041220723475
NIH Device Record Keybdba51c9-3853-422e-aa74-d92947b5700c
Commercial Distribution StatusIn Commercial Distribution
Brand NameH.E.B
Version Model NumberAdvanced One Step Pregnancy Test
Company DUNS007924756
Company NameH. E. BUTT GROCERY COMPANY
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx
Phone1-800-899-7353
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100041220723478 [Primary]
GS100633472000492 [Unit of Use]
GS110041220723475 [Package]
Contains: 00041220723478
Package: Shipping case [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-21
Device Publish Date2021-06-13

On-Brand Devices [H.E.B ]

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

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