FDA.reportPublic FDA data

H-E-B

Primary DI
00041220613076
Brand
H-E-B
Company
H. E. BUTT GROCERY COMPANY
Model
041220613076
Device description
Smart-Flex Bandages, Antibacterial, All one size, 2 3/4 IN x 3 1/2 IN (70 mm x 89 mm)
Published
2020-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20041220613070PackageGS172In Commercial Distribution
00041220613076PrimaryGS10
60041220613078Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2004122061307020041220613070
00041220613076000412206130760412206130760041220613076
6004122061307860041220613078

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cover adhesive strip, antimicrobialA small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device.

Regulatory Flags#

DUNS number
007924756
Device count
7
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041220048632H-E-B0412200486322020-07-27
00041220865468H-E-B inControlG202016-12-13
00197870203805H.E.BSix Days Sooner Pregnancy TestN/A2025-11-28
00197870203812H.E.BSix Days Sooner Pregnancy TestN/A2025-11-28
00633472000690H.E.BSix Days Sooner Pregnancy TestN/A2025-11-28
00041220569311H.E.B Advanced One Step Pregnancy Test2021-06-13
00041220575763H.E.B Advanced One Step Pregnancy Test2021-06-13
00041220575770H.E.B Advanced Early Result Pregnancy Test2021-06-25
00041220575794H.E.B Advanced Early Result Pregnancy Test2021-06-13
00197870203843H.E.BSix Days Sooner Pregnancy TestN/A2025-11-12
00197870203836H.E.BSix Days Sooner Pregnancy TestN/A2025-11-11
00041220723478H.E.B Advanced One Step Pregnancy Test2021-06-13
00197870203829H.E.BSix Days Sooner Pregnancy TestN/A2025-08-15
00633472000683H.E.BSix Days Sooner Pregnancy TestN/A2025-08-15
00041220245970H-E-B156-757-000156-757-0002016-09-12
00041220924837H-E-B156-878-000156-878-0002016-09-12
00041220823222HEB jelly PERSONAL LUBRICANT7W9261JC12021-12-08
00041220524556H.E.B Digital & Early Result Pregnancy Test 2021-06-25
00041220524563H.E.B Digital Pregnancy Test 2021-06-25
00197870071480H.E.BHEB DIG Wide-Tip & VIS PinkN/A2025-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
00819143026446HealquHealqu LLCKGX2026-03-05
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20