FDA.reportPublic FDA data

ABC

Primary DI
10195515047101
Brand
ABC
Company
AMAZON.COM SERVICES LLC
Model
195515047104
Device description
Antibacterial Heavy-Duty Adhesive Bandages, 1 3/4 IN x 4 IN (44 MM x 101 MM)
Published
2024-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
10195515047101PackageGS136In Commercial Distribution
00195515047104PrimaryGS10
60195515047106Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019551504710110195515047101
00195515047104001955150471041955150471040195515047104
6019551504710660195515047106

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18774850385xx@xx.xx

Regulatory Flags#

DUNS number
128990418
Device count
30
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195515153287Amazon Basics6304336304332026-08-07
00195515153294Amazon Basics6304336304332026-08-07
00195515147552Amazon20002241N/A2026-02-20
00195515147545Amazon20002240N/A2026-02-20
00195515050098AmazonDigital Pregnancy TestN/A2025-05-20
00195515045902AmazonEarly Result Pregnancy Test2025-05-20
00195515017947Amazon BasicsB098VHYX2MB098VHYX2M2021-10-27
10195515045909AmazonEarly Result Pregnancy Test2025-05-20
10195515050095AmazonDigital Pregnancy TestN/A2025-05-20
00195515045247Amazon BasicsSQN542025-01-25
10195515045244Amazon BasicsSQN542025-01-25
00195515047944Amazon Basic Care B09S3W7SW72023-12-21
00195515047098ABC1955150470982024-06-25
00195515047104ABC1955150471042024-06-25
10195515047095ABC1955150470982024-06-25
00195515047951Amazon Basic Care B09S3VLQLL2023-12-21
00195515047968Amazon Basic CareB095S3WFGQB2023-12-21
10195515047958Amazon Basic Care B09S3VLQLL2023-12-21
10195515047965Amazon Basic CareB095S3WFGQB2023-12-21
00195515043182Amazon Basic Care B0CJ9T9GKY2023-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00389152744957Adhesive Sleeve, 10 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00389152745459Adhesive Sleeve, 2 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00197998029844Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-05
00311917088556WalgreensWALGREEN CO.KGX2026-09-30
08859922800036EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800043EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800050EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
00850087488877CeeportCEEPORT INC.KGX2026-09-29
00197998095641Transpore™Solventum US LLCKGX2026-09-25
00197998095672Transpore™Solventum US LLCKGX2026-09-25
00197998095702Transpore™Solventum US LLCKGX2026-09-25
00197998095733Transpore™Solventum US LLCKGX2026-09-25
00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25
00197998164118Transpore™Solventum US LLCKGX2026-09-25
06979191883744OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883751OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883768OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883775OKTAPEHTT Technologies, Inc.KGX2026-09-02
00850087488785CeeportCEEPORT INC.KGX2026-08-26
00850087488792CeeportCEEPORT INC.KGX2026-08-26
00197998149016Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149047Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149078Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149382Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149412Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149443Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149474Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23