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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device negative pressure wound therapy non-powered suction apparatus
Regulation Description Nonpowered, single patient, portable suction apparatus.
Definition A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.
Product CodeOKO
Regulation Number 878.4680
Device Class 2

Device Problems
Patient-device incompatibility 1
Incompatibility problem 1
Total Device Problems 2

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