FDA.reportPublic FDA data

Avance® Solo

Primary DI
07323190296705
Brand
Avance® Solo
Company
Mölnlycke Health Care AB
Model
8880050
Device description
Avance Solo Pump and Canister Set
Published
2022-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
07323190310654PackageGS12In Commercial Distribution
07323190296705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07323190310654073231903106547323190310654
07323190296705073231902967057323190296705

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system, electric, single-useA portable assembly of devices designed to apply suction to help heal traumatic and chronic skin wounds (e.g., grafts, incisions, burns, ulcers) with low to moderate levels of exudate. It typically consists of an electrically-powered vacuum pump, a highly-absorbent wound dressing and/or collection canister to contain the exudate, and a connection tube. The pump applies continuous or intermittent negative pressure to the wound via the tube/dressing to decompress capillaries/lymphatic vessels, improve blood/interstitial fluid circulation, draw wound edges together, facilitate granulation tissue formation, and prepare the wound bed for closure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal0
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
631770658
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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07333350904104Mestopore®6650002026-05-06
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07333350976712Tubigrip®14362026-05-06
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05060097937851Biogel® PI408852022-10-21

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Primary DI, Brand, Company table
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00849405002819Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002833Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002840Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
00849405002673Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002680Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002697Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002703Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002710Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002727Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
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00197998032608Solventum US LLCKCI USA, INC.OMP2025-07-29
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