FDA.reportPublic FDA data

Renasys

Primary DI
00040565127286
Brand
Renasys
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
66021066
Catalog number
66021066
Device description
Renasys EZPLUS MAX 800ml S Canister without Solidifier (non-sterile)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142979000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142979000RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX CanistersSmith & Nephew, Inc.2015-04-29OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30040565127287PackageGS110In Commercial Distribution
00040565127286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3004056512728730040565127287
00040565127286000405651272860405651272860040565127286

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system canisterA receptacle for the collection of excess interstitial fluid, exudate, and infectious materials from a dedicated dressing that has been applied for a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT). It is typically made of transparent disposable plastic materials and is connected to or placed into the NPWT system's vacuum pump. This receptacle is a single-use device that should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
216344051
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05000223503284ACTICOAT Flex66027689660276892026-08-25
05000223503697ACTICOAT Flex66027691660276912026-08-25
05000223482589CICA CARE66801491668014912026-04-30
05000223502157CICA CARE66803184668031842026-04-30
05000223502270ACTICOAT Flex66027686660276862026-04-29
05000223502300ACTICOAT Flex66027687660276872026-04-29
05000223502331ACTICOAT Flex66027688660276882026-04-29
05000223502249ACTICOAT Flex66027685660276852026-04-28
05000223502218ACTICOAT FLEX66027684660276842026-03-26
05000223503727ACTICOAT Flex66027683660276832026-03-26
05000223503956LEAF66807739668077392026-03-03
05000223503994LEAF66807745668077452026-03-01
00040565117737COVRSITE5971430059714300 / 597144002026-01-19
00040565117690COVRSITE5971400059714000 / 597141002026-01-19
00040565120249COVRSITE59715000597150002026-01-19
00040565120263COVRSITE59715100597151002026-01-19
00040565117706COVRSITE5971400059714000 / 597141002026-01-19
00040565117744COVRSITE5971430059714300 / 597144002026-01-19
00040565120256COVRSITE59715000597150002026-01-19
00040565120270COVRSITE59715100597151002026-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719873697724NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697731NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697748NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697755NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697762NACARILEX MEDICAL, INC.OMP2026-08-26
00197998301209Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00197998301285Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00197998301360Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00850084501005Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501029Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501036Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501043Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501050Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501067Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00197998301148Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998301162Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998303906Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998276507Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998300912Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998300936Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313660Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313691Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313752Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313783Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313844Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313905Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00840117350984Durma+ Flexible Suction Bell, With TubingDynarex CorporationOMP2026-06-22
00197998382819Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00197998382895Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22