UNO 10x40 Dressing Kit

GUDID 00849405021537

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 foam dressing, non-antimicrobial

• Primary Device ID: 00849405021537
• NIH Device Record Key: c6cee38d-9082-4d08-a365-e87a5537ca05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNO 10x40 Dressing Kit
• Version Model Number: UNO-0416
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849405021537 [Primary]

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

Ethylene Oxide

[00849405021537]

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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• 00849405000501 - AG Spiro Foam Kit: 2025-01-29 XLR8 PU Foam with AG Kit, Spiro
• 00849405022114 - AG Foam Kit Small: 2025-01-29 XLR8 PU Foam with AG Kit, Small
• 00849405022121 - AG Foam Kit Medium: 2025-01-29 XLR8 PU Foam with AG Kit, Medium
• 00849405022138 - AG Foam Kit Large: 2025-01-29 XLR8 PU Foam with AG Kit, Large