FDA UDI
In Commercial Distribution
🇺🇸 United States
Negative Pressure Wound Therapy System Foam Dressing
DI: B530UTD250
·
Model: UTD24
·
LC MEDICAL CONCEPTS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Negative Pressure Wound Therapy System Foam Dressing
- Primary DI
- B530UTD250
- Version / Model
- UTD24
- Catalog Number
- UTD24
- Company Name
- LC MEDICAL CONCEPTS
- Labeler DUNS
- 093992526
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-23
- Public Version
- 2
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- 8a99df53-e2e0-448a-b7a0-520b6ce60926
Device Description
NPWT Ported Dome pad
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
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 |
|---|---|---|---|---|
| 47406 | Negative-pressure wound therapy system foam dressing, non-antimicrobial | A pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B530UTD241 | HIBCC | box | 10 | In Commercial Distribution | |
| Primary | B530UTD250 | HIBCC |