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This device is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

The subject device is a polypropylene plastic syringe filled with 0.9% Sodium Chloride for Injection, USP, and capped with a polypropylene plastic cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12 mL syringe with a 3 mL, 5 mL, or 10 mL fill volume.

For Prescription Use: For easing the insertion of medical devices such as scopes and catheters into body orifices.

The subject device is a terminally gamma sterilized 10cc polypropylene plastic syringe filled with United Guardian lubricating jel and capped with a polypropylene plastic cap. United Guardian has a Master File Reference for its lubrication jel, Master File for Devices MAF-613 pertaining to Lubrajel RR. All components of the device are gamma irradiation stable.

For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. For Prescription Use: For moistening absorbent wound dressings and for moistening, . debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

The Wound Flush, Sterile Water & Sterile Normal Saline device is a wound and device cleansing solution that is intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile saline for irrigation and meets all of the associated requirements defined in the USP <31>. The subject device is offered in various bottle and cup sizes with and without a spray applicator