21 CFR 880.5740 — Snake Bite Suction Kit

General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5740

Identification

A suction snakebite kit is a device consisting of a knife, suction device, and tourniquet used for first-aid treatment of snakebites by removing venom from the wound.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KYPSnake Bite Suction Kit14
PWXInsect Sting Emergency Kit10
Innolitics

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