UNO 15 Therapy Kit 10x10

GUDID 00849405000532

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.

GENADYNE BIOTECHNOLOGIES INC.

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• Primary Device ID: 00849405000532
• NIH Device Record Key: b261ed34-f19d-4275-bd22-a19469931874
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNO 15 Therapy Kit 10x10
• Version Model Number: U-S1010-5
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00849405000532 [Primary]

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: 2023-06-19
• Device Publish Date: 2023-06-09

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: 2023-06-21 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: 2023-06-19The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
• 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