Durma+ Large Foam Dressing Kit, Large, 10" x 5.9" Foam

Basic Information

• Brand Name: Durma+ Large Foam Dressing Kit, Large, 10" x 5.9" Foam
• Primary DI: 00840117342316
• Version / Model: 3125
• Company Name: Dynarex Corporation
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-03
• Public Version: 1
• Public Version Date: 2025-06-11
• Public Version Status: New
• Public Device Record Key: ee7b0fe2-aba6-4dd3-ac1b-2f4162b750e0

Device Description

Sterile-R, Sterile-EO, Content: 1- Foam, Large, 10" x 5.9", 1- Suction Bell with Tubing, 1- Transparent Wound Drape

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61145	Irrigation negative-pressure wound therapy dressing	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840117342316	GS1
Package	00840117342286	GS1	Case	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K182458	000