UNO NPWT 70CC Collection Canister

Basic Information

• Brand Name: UNO NPWT 70CC Collection Canister
• Primary DI: 00849405001058
• Version / Model: U-C070
• Company Name: GENADYNE BIOTECHNOLOGIES INC.
• Labeler DUNS: 006616130
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-08
• Public Version: 1
• Public Version Date: 2023-06-16
• Public Version Status: New
• Public Device Record Key: 3e3e7c32-0637-4be0-b1a7-7f541b3d8955

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47404	Negative-pressure wound therapy system canister	A receptacle for the collection of excess interstitial fluid, exudate, and infectious materials from a dedicated dressing that has been applied for a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT). It is typically made of transparent disposable plastic materials and is connected to or placed into the NPWT system's vacuum pump. This receptacle is a single-use device that should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849405001058	GS1