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Code · CFR · Title 21 — Food and Drugs · Part 880 — General Hospital and Personal Use Devices · § 880.5410

§ 880.5410. Neonatal transport incubator.

79 words·~1 min read·/us/cfr/t21/s§ 880.5410·

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(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).
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