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U.S. Department of Health and Human Services

Product Classification

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Device blanket, neonatal phototherapy
Definition 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.
Physical State Comprised of a light-weight, spun bond polypropylene material. Spun bond polypropylene is a commonly used fabric in medical products and garments. The material is non-irritating to the skin, soft, and allows it to easily conform to body contours. The material is available in different fabric weights, depending on the tightness of the weave and fabric density. The spun bond polypropylene fabric has a generally open-weave structure to ensure maximum light transmittance through the fabric.
Technical Method Comprised of a light-weight, spun bond polypropylene material. The blanket is intended to allow an infant undergoing phototherapy for hyperbilirubinemia to be tightly swaddled and still receive the full benefit of the phototherapy treatment. The design of the blanket allows the infant to be swaddled in a fashion such that only a single layer of fabric is ever interposed between the infant and the phototherapy light source.
Target Area Whole body.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePDH
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons