21 CFR 880.5700 — Unit, Neonatal Phototherapy

General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5700

Identification

A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
LBIUnit, Neonatal Phototherapy2713rd Party
PDHBlanket, Neonatal Phototherapy223rd Party
PWNBaby Care Kit20
Innolitics

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