b'For Health Care Practitioners.See Patient and Caregiver Instruction for information for Patients and Caregivers.PRESCRIPTION DEVICECaution: Federal law restricts this device to sale or use by or on the order of a physician.DESCRIPTIONTheNP SIMS Negative Pressure Surgical Incision Management System by Aatru Medical, LLC is a single-use medical device consisting of a non-sterile vacuum chamber and sterile dressing and tubing kit. TheNP SIMS is intended for use with closed incisions with low exudate up to 10ml, or over a period of up to 7 days. The disposable vacuum chamber initially generates a peak negative pressure of -1005mmHg at the wound surface, and maintains a continuous, linear rate of pressure decline to -60mmHg over 7 days (nominally, 80mmHg20mmHg). Wound exudate is managed by the absorptive dressing technology. The tubing can be cut to length based upon patient needs. Making use of a fully pre-assembled wound contact dressing, theNP SIMS operates silently without the use of an external electromechanical pump nor collection canister, enabling discrete patient portability. The duration of treatment is dependent upon the recommendation of the treating physician. After use, all components of theNP SIMS are disposed of as clinical waste in accordance with local protocols and regulations.NP SIMS Health Care Practitioner Instructions for Use (IFU)1'