Baxter 2C8891 – EXTENSION, SET, CONTROL-A-FLO, EACH
Straight-Type Extension Set, Standard Bore, CONTROL-A-FLO Regulator, CLEARLINK Luer Activated Valve, Retractable Collar, 19″ (47 cm)
Extension Sets with CONTROL-A-FLO Regulator
Extension Set with CONTROL-A-FLO Regulator and a CLEARLINK Luer Activated Valve and Male Luer Lock Adapter with Retractable Collar. Approximate Volume 3.3 mL. Approximate Length 19″ (47 cm). Contains 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.
Diethyl hexyl Phthalate, A chemical commonly used in PVC tubing; used to yield clarity and soft pliable tubing.