UNO NPWT 70CC Collection Canister

GUDID 00849405001058

The UNO Canister comes in only 1 size, which is 70cc. It has a solidifier gel sheet inside to solidify any collected exudates. The canister is made out of ABS plastic material. At the suction interface, where it is connected to the UNO pump, there is a hydrophobic filter welded to it. The filter has a 0.2 micron pore size, which has a bacteria filtration efficiency (BFE) of over 99%. The UNO canister is a disposable single use item. It comes packaged in a medical grade paper pouch.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system canister

• Primary Device ID: 00849405001058
• NIH Device Record Key: 3e3e7c32-0637-4be0-b1a7-7f541b3d8955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNO NPWT 70CC Collection Canister
• Version Model Number: U-C070
• 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	00849405001058 [Primary]

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

[00849405001058]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-16
• Device Publish Date: 2023-06-08

Devices Manufactured by GENADYNE BIOTECHNOLOGIES INC.

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• 00849405000402 - 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
• 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.
• 00849405001638 - 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(
• 00849405001645 - 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(
• 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(