Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
§ 880.5410 - Neonatal transport incubator.

(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).

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.
cite as: 21 CFR 880.5410