UNO Plus Negative Pressure Wound Therapy Device

GUDID 00849405000495

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.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric

• Primary Device ID: 00849405000495
• NIH Device Record Key: 37c2f892-e1f3-4a07-9830-e0f2f2065d94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNO Plus Negative Pressure Wound Therapy Device
• Version Model Number: UP-S01
• Company DUNS: 006616130
• Company Name: GENADYNE BIOTECHNOLOGIES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849405000495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210107

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

Devices Manufactured by GENADYNE BIOTECHNOLOGIES INC.

• 00849405000013 - XLR8 Transparent Film Dressing: 2023-12-27 Polyurethane film with medical grade acrylic adhesive, size 26 x 30 cm.
• 00849405001454 - XLR8/XLR8+ Port: 2023-12-27 Medical grade suction port that has a PU film with acrylic adhesive attached to it.
• 00849405000389 - UNO Plus 200 CC Collection Canister: 2023-06-21 All canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes:
• 00849405000488 - UNO Plus 300 CC Collection Canister: 2023-06-21 All canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes:
• 00849405000495 - UNO Plus Negative Pressure Wound Therapy Device: 2023-06-21The 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.
• 00849405000495 - UNO Plus Negative Pressure Wound Therapy Device: 2023-06-21 The Genadyne UNO+ NPWT (Ref # UP-S01) is a multi-patient use, rechargeable Negative Pressure Wound Therapy unit, designed for mo
• 00849405000525 - UNO 10x10 Dressing kit: 2023-06-19 The UNO Dressing is constructed with 4 different layers. The top layer is a polyurethane material, where the suction port is att
• 00849405000532 - UNO 15 Therapy Kit 10x10: 2023-06-19 The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The
• 00849405000549 - UNO 7 Therapy Kit 10x10: 2023-06-19 The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The