Baxter 2H8603 – Clearlink 12 Micron Ext. 48/Ca
Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19″ (47 cm)
Extension Set with 1.2 Micron Filter, CLEARLINK Luer Activated Valve and Male Luer Lock Adapter. Approximate Volume 5.3 mL. Approximate Length 19″ (47 cm). 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|
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.
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.