FDA.reportPublic FDA data

Avance® Solo

Primary DI
07323190297689
Brand
Avance® Solo
Company
Mölnlycke Health Care AB
Model
881520
Device description
Avance Solo Border Dressing 15x20 cm
Published
2022-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
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
K203369000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203369000Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC2021-07-01OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07323190297689PackageGS12In Commercial Distribution
07323190310500PackageGS12In Commercial Distribution
07323190236015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07323190297689073231902976897323190297689
07323190310500073231903105007323190310500
07323190236015073231902360157323190236015

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
631770658
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333350012946Mepiform®2932112026-10-29
07333350064938Biogel® PI Micro Indicator® Underglove66489702026-10-29
07333350119621Biogel® PI Micro Indicator® System66483702026-10-29
07333350176181Biogel® PI Micro Indicator® Underglove66489602026-10-29
07333350400149Mepiform®2931112026-10-29
07333350407926Biogel® PI Micro Indicator® System66483652026-10-29
07333350581305Biogel® PI Micro Indicator® System66483602026-10-29
07333350600297Mepiform®2934012026-10-29
07333350696177Biogel® PI Micro66485652026-10-29
07333350861582Biogel® PI Micro Indicator® Underglove66489652026-10-29
07333350974121Biogel® PI Micro66485602026-10-29
07333350999124Biogel® PI Micro Indicator® Underglove66489752026-10-29
07333350811372Biogel® PI Micro66485702026-10-20
07333350937461Mepiform®2931992026-10-20
07333350635428Mepiform®2934992026-10-16
07333350898588Mepiform®2932992026-10-16
07333350181475Mölnlycke®Z-Flo™ Fluidized Positioner14005002026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized Positioner14005222026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized Positioner14005132026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized Positioner14005272026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05000223505134ABDO ShieldSMITH & NEPHEW MEDICAL LIMITEDOMP2026-11-03
00749756402316DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402323DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402330DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402347DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402354DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402361DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402378DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00850084501920Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501937Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501944Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501951Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00749756369640DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-23
00749756985475DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756985963DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756985994DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756986250DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756401289DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
00749756401692DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
00749756401746DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
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