Baxter 2C5645 - SET EXTENSION WITH LUER LOCK ADAPTOR 48/CS

Straight-Type Extension Set , Standard Bore, Retractable Collar, 29" (75 cm)

Extension Set Male Luer Lock Adapter with Retractable Collar. Approximate Volume 3.9 mL. Approximate Length 29" (75 cm). Contains DEHP. Sterile package, Nonpyrogenic.

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

Pyrogen-free

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.