21 CFR § 880.5410 General Hospital and Personal Use Devices

§ 880.5410 Neonatal transport incubator.

Current through Sep 8, 2026 · Read all of Part 880

(a) Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.

(b) Classification. Class II (performance standards).

← § 880.5405 Active noise attenuation system for infant incubators.§ 880.5420 Pressure infusor for an I.V. bag. →