Blanket, Neonatal Phototherapy

FDA product code PDH · Class II (moderate risk) · 21 CFR 880.5700 · General Hospital

Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.

2510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K142416Luma WrapPDH · Traditional Salter Labs06/12/2015SE
K123411Little Angels Swaddling BlanketPDH · Traditional Bionix Development Corp.03/07/2013SE

Recalls

RecallProductFirmInitiated
Z-2181-2014 Class IILuma Wrap Phototherapy Swaddler is designed to provide centered and comfortable…Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the… Beevers Manufacturing & Supply, Inc.07/11/2014Terminated