FDA.reportPublic FDA data

"Durma+ Medium Foam Dressing Kit, Medium, 7"" x 4.7"" Foam"

Primary DI
00840117342309
Brand
"Durma+ Medium Foam Dressing Kit, Medium, 7"" x 4.7"" Foam"
Company
Dynarex Corporation
Model
3124
Device description
"Sterile-R, Sterile-EO: Contents: 1- Foam, Medium, 7"" x 4.7"" , 1- Suction Bell with Tubing, 1- Transparent Wound Drape"
Published
2025-06-03
Public version status
New
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
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
K182458000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182458000Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.2019-05-23OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117342279PackageGS110In Commercial Distribution
00840117342309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117342279008401173422798401173422790840117342279
00840117342309008401173423098401173423090840117342309

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation negative-pressure wound therapy dressingA sterile dressing intended to treat open wounds (e.g., acute, traumatic, and chronic) that can only heal by secondary intention, through use of suction combined with instillation/aspiration of wound treatment solutions (e.g., saline) over the wound bed provided by an irrigation negative-pressure wound therapy unit. It typically consists of a foam dressing, polymer drape and attached tubing. It is intended to help reduce oedema, promote granulation tissue formation, and remove exudates and infectious material. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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Primary DI, Brand, Company table
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00850084501937Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
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