FDA.reportPublic FDA data

Prevahex

Primary DI
B5591483CH00
Brand
Prevahex
Company
ENTROTECH LIFE SCIENCES, LLC
Model
1483CH
Catalog number
1483CH
Device description
Prevahex Antimicrobial Transparent Film Dressing
Published
2019-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K140389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140389000CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4Entrotech Life Sciences, Inc.2014-11-07FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5591483CH00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial synthetic polymer semi-permeable film dressing, adhesiveA sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue to provide protection (e.g., from dirt, water) and/or promote healing, and that contains an antimicrobial agent. It is a thin, clear film made of synthetic polymer with a pressure-sensitive adhesive on one side that may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions, ulcers, burns, lacerations, abrasions, device insertion sites, and donor/graft sites. It may also be used to secure to skin other devices (e.g., catheters, drains, leads, ports). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
120331037
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003436424Multi-T2021KS2025-06-30
00860003436455Multi-T2021KB2025-06-30
B5591491BOX1Prevahex1491BOX1491BOX2021-02-26
B5591492BOX1Prevahex1492BOX1492BOX2021-02-26
B5591483BOX1Prevahex1483BOX1483BOX2019-12-16
B5591484BOX1Prevahex1484BOX1484BOX2019-12-16
B5591484CH00Prevahex1484CH1484CH2019-12-16
B5591485BOX1Prevahex1485BOX1485BOX2019-12-16
B5591485CH00Prevahex1485CH1485CH2019-12-16
B5591488BOX1Prevahex1488BOX1488BOX2019-12-16
B5591488CH00Prevahex1488CH1488CH2019-12-16

Other Devices Sharing Product Codes#

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