FDA UDI
In Commercial Distribution
🇺🇸 United States
Durma+ Small Foam Dressing Kit, Small, 4" x 2" Foam
DI: 00840117342293
·
Model: 3123
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Durma+ Small Foam Dressing Kit, Small, 4" x 2" Foam
- Primary DI
- 00840117342293
- Version / Model
- 3123
- 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
- 95041cd0-328a-430b-95a2-36f3803aa756
Device Description
Sterile-R, Sterile-EO: Contents: 1- Foam, Small, 4" x 2", 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 | 00840117342293 | GS1 | ||||
| Package | 00840117342262 | GS1 | Case | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182458 | 000 |