FDA.reportPublic FDA data

CVS Health

Primary DI
00050428339770
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
16CVS01507NEW
Catalog number
329198
Device description
Nano Silver Wound Wash 4 fl. oz. [118.29 mL]
Published
2026-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
K151185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151185000AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)Abl Medical, LLC2016-02-05FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00050428339770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428339770000504283397700504283397700050428339770

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solutionA solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
1 (888) 7717824info@trikits.com
9095941220junb@trikits.com
9095941220ederlyne@trikits.com
9095941220dennisn@trikits.com
9095941220jayey@trikits.com

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
true
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
00050428269381CVS Health9965529965522016-09-21
00050428143216CVS0504281432162026-08-18
00050428124505CVS Health8448202026-08-14
00050428034873CVS Health5518372026-08-08
00050428034880CVS Health5518362026-08-08
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
00050428142516CVS0504281425162026-05-28
00050428044940CVS6158032026-05-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
05000223503697ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998002861Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173523Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432415Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28