AURUM2 OPAQUE UROSTOMY BAG FLANGE DIAMETER 45 MM 15 PIECES

Directions for use
Collection of waste products for urostomy patients.

Characteristics
Two-piece urostomy pouch, transparent or opaque, anatomically shaped, with a flange for attachment to the baseplate, lined on the body side with a soft non-woven fabric, available in opaque or transparent versions. The opaque version is lined on the outside with a special material that not only reduces noise but also prevents unpleasant friction with clothing. Equipped with an anti-reflux and drainage system, it can be connected to a leg or bed collector.

Package Contents
Urostomy bags.

Product Range

Code product	Amount	Type	Diameter (mm)	Opaque/ Transparent
XMH2U145	15	Maxi	45 mm	Opaque
XMH2U155	15	Maxi	55 mm	Opaque
XMH2U345	15	Maxi	45 mm	Transparent
XMH2U355	15	Maxi	55 mm	Transparent

Presence of latex, phthalates, drugs, substances, biological tissues

DESCRIPTION	YES	NO
Latex		X
DEHP		X
Drugs		X
Substances		X
Organic Fabrics		X

Building material
PVC, hypoallergenic polyethylene non-woven fabric.

Sterilization specifications
Product validity: 5 years from date of manufacture.
Single-use, non-sterile and non-resterilizable product.

Chemical-physical incompatibility of materials
Chemical-physical incompatibility of materials with substances with which they may potentially come into contact:
• fats and oils, such as petroleum jelly and paraffin oil;
• organic solvents such as benzene and ether;
• oxidizing materials such as hydrogen peroxide, sulfur, hypochlorite;
• disinfectants containing phenol or similar.

Packaging methods
The product packaging has been designed to ensure optimal preservation and easy stacking. Each package clearly and legibly displays, in Italian, a qualitative and quantitative description of the contents, the manufacturer's name, and any other information useful for immediate product identification. The individual packages are easy to open, preventing material from sticking to the packaging, making it easier to remove the product.

Material used for primary packaging
The primary packaging consists of a cardboard box.

Quantity per secondary package
The package contains 15 pieces , packed in bags of 5 pieces.

Storage methods
Store at room temperature, away from direct light. Prolonged exposure to fluorescent light, sunlight, or heat will damage the device.

Disposal methods
Check the instructions provided by Italian regulations regarding the disposal of medical devices.

Quality controls
Devices are designed and manufactured in such a way that their use does not compromise the clinical condition and safety of patients, nor the safety and health of users and, where applicable, third parties, when used under the conditions and for the purposes intended.
Quality control, carried out in accordance with international standards, involves a series of checks at every stage of production. Each production batch undergoes constant technical, chemical, and biological testing from the moment the raw materials are used until sterilization.
The Welland Quality System complies with the Quality Assurance requirements set forth in European Directive 93/42/EEC and the ISO 9001 and ISO 13485 standards.

How to use and contraindications
Please refer to the product instructions for use.