FDA.reportPublic FDA data

CVS Health

Primary DI
00050428034880
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
551836
Device description
Flexible Fabric Antibacterial Bandages, assorted sizes, 5/8 IN x 2 1/4 IN (15 mm x 57 mm), 3/4 IN x 3 IN (19 mm x 76 mm), 1 IN x 3 IN (25 mm x 76 mm),30CT
Published
2026-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200821000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200821000anti-bacterial bandagePlanet (Suzhou) Medical Products Co., Ltd.2020-10-19FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00050428034880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428034880000504280348800504280348800050428034880

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
062312574
Device count
1
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
true
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
00050428143315CVSCVS489905V22026-09-18
00050428340561CVSCVS469682V22026-09-18
00050428269381CVS Health9965529965522016-09-21
00050428339770CVS Health16CVS01507NEW3291982026-03-20
00050428143216CVS0504281432162026-08-18
00050428124505CVS Health8448202026-08-14
00050428034873CVS Health5518372026-08-08
00050428167335CVSMD300CN330R2026-07-10
00050428167342CVSMD300C2052026-07-10
00050428426777CVS HealthCVS991268RR2026-06-24
00050428005873CVS695540BC332025-11-19
00050428280669CVS HealthCVS5248V12026-06-04
00050428359112CVS HealthCVS739091V12026-06-04
00050428453599CVS HealthCVS9107552026-06-04
10050428265106CVS Glucose Meter8000-107532021-03-22
00050428050460CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428082102CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087268CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087589CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428049556CVS Health6 Days Sooner Pregnancy TestN/A2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072273Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072280Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072457SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072464SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072471SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072488SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
10192253072723CurityCardinal Health 200, LLCFRO2026-10-08
10192253072730CurityCardinal Health 200, LLCFRO2026-10-08
10192253072747CurityCardinal Health 200, LLCFRO2026-10-08
10192253072754CurityCardinal Health 200, LLCFRO2026-10-08
10192253072761CurityCardinal Health 200, LLCFRO2026-10-08
10192253072778CurityCardinal Health 200, LLCFRO2026-10-08
10192253072785CurityCardinal Health 200, LLCFRO2026-10-08
10192253072792CurityCardinal Health 200, LLCFRO2026-10-08
10192253072808CurityCardinal Health 200, LLCFRO2026-10-08
10192253072815CurityCardinal Health 200, LLCFRO2026-10-08
10192253072822CurityCardinal Health 200, LLCFRO2026-10-08
00860014518331PurForm AMKAIROS BIOSCIENCES LLCFRO2026-10-07
00860014518348PurForm AMKAIROS BIOSCIENCES LLCFRO2026-10-07
00886333217595V+PadARGON MEDICAL DEVICES, INC.FRO2026-10-07
00612553000163VERISHARTMANN USA, INC.FRO2026-10-01
00612553000170VERISHARTMANN USA, INC.FRO2026-10-01
00612553000187VERISHARTMANN USA, INC.FRO2026-10-01
00612553000194VERISHARTMANN USA, INC.FRO2026-10-01
00194346726707equateWAL-MART STORES, INC.FRO2026-09-30
00194346726714equateWAL-MART STORES, INC.FRO2026-09-30
10885380214714CurityCardinal Health 200, LLCFRO2026-09-30
10885380214738CurityCardinal Health 200, LLCFRO2026-09-30