Baxter 2C1146 - ADMIN IV SET EMULSION NVNT, 48/CS
IV Fat Emulsion Administration Set, Non-Vented, 60 drops/mL, 86" (2.2 m), Non-DEHP
Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar
IV Fat Emulsion Administration Set
IV Fat Emulsion Administration Set with Non-Vented Spike and Male Luer Lock Adapter with Retractable Collar. Approximately 60 drops/mL. Approximate Length 86" (2.2 m). Non-DEHP. Fluid path is sterile, nonpyrogenic.
|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|
|Prescription Use (Rx):||Yes|
|Over the Counter (OTC):||No|
|Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):||No|
|Device Packaged as Sterile:||Yes|
|Requires Sterilization Prior to Use:||No|
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:
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.
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.
Whenever plastics are used in direct contact with the patients tissue or blood, a high degree of compatibility is essential between the tissue/blood and 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.
PVC in medical products
The use of PVC in medical devices represents a very minor percentage of the total amounts of PVC manufactured each year. Nonetheless the use of plasticized PVC in a wide range of medical devices has been very important for a number of reasons.
- Flexibility in a variety of physical forms from tubes to membranes.
- Chemical stability and possibility to sterilise.
- Low cost and wide availability.
- Lack of evidence of significant adverse consequences in patients.
Pyrogen is any substance that causes a fever. The most commonly thought of pyrogens are bacterial endotoxins and exotoxins, although the host body (human or animal) can also produce pyrogens. The most commonly assayed for pyrogen is lipopolysaccharide, or LPS. It is a component of the bacterial wall of Gram-negative bacteria and is released upon breakdown of the cell wall or bacterial cell lysis.
Pyrogen-free products are manufactured in settings that prevent the deposition of bacteria and other agents on the products.
Our IV sets are DEHP free. Infusion Therapy Standards of Practice advise to usee administration sets free of di-ethylhexyl-phthalate (DEHP) to administer lipid-based infusates, such as IVFE or TNA. DEHP is lipophilic and is extracted into the lipid solution with commonly used polyvinyl chloride administration sets and containers. DEHP is considered a toxin, and studies have demonstrated increased DEHP levels in lipid solutions, which is especially a risk with neonatal, pediatric, and long-term home care patients (42).