Empty INTRAVIA Container with Non-DEHP Fluid Path, 250 mL

INTRAVIA Container, 250 mL Capacity

Empty INTRAVIA Container with Non-DEHP Fluid Path, 250 mL

INTRAVIA Plastic Container systems

INTRAVIA Container, 250 mL Capacity
The solution contact materials in empty 2J INTRAVIA Container
Radiation - Gamma sterilized

Cautions

Squeeze and inspect filled bag
Discard if leaks are found
Must not be used in series connections

Contains DEHP

Diethyl hexyl Phthalate, A chemical commonly used in PVC tubing; used to yield clarity and soft pliable tubing.

Contains PVC

Polyvinyl chloride (PVC) plastic is used to manufacture a huge number of articles for daily life, e.g. toys, building material such as flooring, cables, as well as medical products. PVC is the most widely used thermoplastic material in medical devices due to its:

Safety

Before medical devices can be used all the components must be fully understood from a toxicological point of view. Consequently all the materials used to make such components have to be thoroughly tested and assessed in the EU before being accepted. Experience based on all available knowledge from international environmental and healthcare authorities shows that PVC is safe. It is the best material existing today which optimises all performance and safety requirements at lowest cost.

Chemical stability

Material used in medical applications must be capable of accepting or conveying a variety of liquids without themselves undergoing any significant changes in composition or properties.

Biocompatibility

Whenever plastics are used in direct contact with the patients tissue or blood, a high degree of compatibility is essential between the tissue/bloodand the material. The significance of this property increases with time over which plastic is in contact with the tissue or blood.PVC is characterised by high biocompatibility, and this can be increased further by appropriate surface modification.

Clarity and transparency

Because of its physical properties, products made from PVC can be formulated with excellent transparency to allow for continual monitoring of fluid flow. If colour-coded application is needed, virtually any colour can be created.

Flexibility, durability and dependability

Not only does PVC offer the flexibility necessary for applications such as blood bags and IV containers, but can also be relied upon for its strength and durability, even under changing temperatures and conditions.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

Sterilization

Device Packaged as Sterile:	Yes
Requires Sterilization Prior to Use:	No

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