UNO 10x20 Dressing Kit

GUDID 00849405021513

The UNO Dressing is constructed with 4 different layers. The top layer is a polyurethane material, where the suction port is attached to. The 2nd layer is a super absorbent layer, 3rd layer is a foam layer, and the bottom layer that is skin/ wound contacting is a silicone gel adhesive layer.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system, electric, single-use

• Primary Device ID: 00849405021513
• NIH Device Record Key: 9d0ef007-f810-4ee3-be8d-e6f9e888cd42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNO 10x20 Dressing Kit
• Version Model Number: UNO-0408
• Company DUNS: 006616130
• Company Name: GENADYNE BIOTECHNOLOGIES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849405021513 [Primary]

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

[00849405021513]

Ethylene Oxide

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.

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• 00849405000419 - XLR8 Canister: 2024-08-13 All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates
• 00849405000426 - XLR8 Canister: 2024-08-13 All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates.
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• 00849405001652 - Hybrid Dressing: 2024-08-08 The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP-D1050(10 cm x 50 cm), UP-D1030(