CozeeCoo, LLC

CozeeCoo, LLC manufactures the CozeeCoo®, a wearable infant positioning blanket and FDA-registered Class I medical device designed to prevent self-interference at the chest and above in infants aged newborn to 15 months. The product is engineered to deter hand contact with post-procedure medical sites, medical devices, topical medications, and areas affected by severe skin irritation or repetitive hand contact (such as eczema, cleft lip/palate recovery, or surgical sites). Made from Global Organic Textile Standard (GOTS) certified 100% organic cotton with hypoallergenic properties (free from nickel, toxic dyes, bleach, formaldehyde, and fragrances), the garment is washer, iron, and dryer safe. The CozeeCoo® features mobile arms that allow limb and body movement while restricting access to the chest area, and is suitable for use during sleep, diaper changes, and in standard car seats. The device is labeled with Unique Device Identification (UDI) barcodes for improved patient safety and surveillance. CozeeCoo® is FDA-listed and registered in the United States; sold internationally as a wearable baby blanket. The company offers multiple size options (Newborn/Preemie through 12-15 months) based on WHO child growth standards. Eligible for HSA/FSA/HRA reimbursement with a Letter of Medical Necessity. Fulfillment center located in New Jersey; ships globally via DHL, UPS, and USPS. Product launched March 2021; recognized as a TIME Best Invention 2023. Healthcare facility partnerships available; product is stocked in pediatric hospitals across the United States.