UNO Plus Negative Pressure Wound Therapy Device
Basic Information
- Brand Name
- UNO Plus Negative Pressure Wound Therapy Device
- Primary DI
- 00849405000495
- Version / Model
- UP-S01
- Company Name
- GENADYNE BIOTECHNOLOGIES INC.
- Labeler DUNS
- 006616130
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-13
- Public Version
- 1
- Public Version Date
- 2023-06-21
- Public Version Status
- New
- Public Device Record Key
- 37c2f892-e1f3-4a07-9830-e0f2f2065d94
Device Description
The Genadyne UNO+ NPWT (Ref # UP-S01) is a multi-patient use, rechargeable Negative Pressure Wound Therapy unit, designed for moderate to low severity wounds. The UNO+ NPWT features an interface panel which provides 5 alerts to the user, selectable therapy modes (continuous mode and variable mode) and multi pressure options (40mmHg, 60mmHg,80mmHg, 100mmHg or 125mmHg). The UNO+ NPWT is packaged in a box that includes a universal charger, USB cable, a user manual and a user carry bag. It will be made compatible with the dressing kits that was already approved under K143726. The dressing kits includes the transparent film dressings, a choice of wound filler (i.e. XLR8 green foam, Genadyne Hybrid Dressing) and the XLR8 Port Pad. The UNO+ NPWT is designed to be used with a canister collection system. The canister will have 2 sizes available (200cc and 300cc). Therapy duration of the dressing may be less than indicated if clinical practice or other factors such as wound type, wound size, rate or volume of exudate, orientation of the dressing or environmental conditions, result in more frequent dressing changes.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 47408 | Negative-pressure wound therapy system pump, electric | A mains electricity (AC-powered) device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. It is typically a computer-controlled vacuum pump with controls and display for continuous or intermittent negative pressure delivered through a tubing set to the open-cell foam dressing located at the airtight-sealed wound. It typically has internal batteries that allow the device to operate for a short period without line power (e.g., during transport or a power outage). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849405000495 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210107 | 000 |