A Novel Cooling Device for Pain Management During Fingerstick Blood Draw

Exclusion Criteria

• •• Subject has had a surgical procedure(s) in the intended area of treatment in the last 6 months.
• •* Sensitivity to the cold or history of cold-induced diseases including Raynaud's disease and cryoglobulinemia
• •* Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• •* Suffering from significant skin conditions in treatment areas or inflammatory skin condition, including but not limited to open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Principal Investigator's discretion) or during the treatment course.
• •* History of keloid scarring, abnormal wound healing and /or prone to bruising.
• •* History of epidermal or dermal disorders (Particularly if involving collagen or micro vascularity) including collagen vascular disease or vasculitis disorders
• •* Subject is unable or unwilling to comply with the study requirements.
• •* Subject is currently enrolled or has been enrolled within the prior 3 months in a clinical study of any other unapproved investigational drug or device.
• •* Any other condition that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.