Bruder Moist Heat and Cold Sinus Compress

About the Product

A reusable fabric compress contoured for the face, sized to cover the sinus area and forehead, with ties to hold it in place. It can be heated in a microwave for moist heat or chilled in a freezer for cold. It is filled with MediBeads, which absorb water molecules from the air and release that moisture as moist heat when the compress is warmed, so no water is added before use. It is latex free, washable and reusable.

This is the sinus size, shaped for the face rather than the eyes, and it is used either warm from the microwave or cold from the freezer. Warm, it is worn over the sinus area and forehead for up to 30 minutes; cold, it is chilled for 2 hours first and then applied to the same area.

Materials

• MediBeads fill Beads with a honeycomb shaped pore that absorb only water molecules from the air and release that moisture as moist heat when the compress is warmed, so no water is added before use.
• Fabric shell The washable fabric that encloses the beads and holds the contoured shape that covers the sinus area and forehead, measuring 8 3/4 inches by 5 1/2 inches across the facial area.
• Ties The fabric ties that keep the compress in place on the face during use.

What Is Included

• One Bruder Sinus Compress with ties

Specifications

How to Use

1. Microwave the compress for 1 to 2 minutes.
2. Touch test the compress before applying it, since microwave ovens vary greatly.
3. Apply to the area for up to 30 minutes.

1. Place the compress in the freezer for 2 hours, or store it in the freezer between uses.
2. Apply to the area.

Care and Cleaning

• Hand washable. Use a mild soap in cold water, or surface clean with a damp sponge.
• Air dry for 24 hours before reusing.
• Do not wash in hot or warm water.
• Do not machine wash or dry.

Warnings

• Touch test the compress before applying it. Microwave ovens vary greatly, so use a medium setting.
• Remove racks and shelves from the microwave prior to heating.

Regulatory

This product is listed with the FDA by The Hilsinger Company Parent, LLC, 575 West Street, Suite 120, Mansfield, MA 02048, under FDA establishment registration number 1039131. In that registration the proprietary names Bruder and MediBeads appear under product code IMA, device name "Pack, Heat, Moist", regulation number 21 CFR 890.5730, device class 1, and also under product code IME, device name "Pack, Hot Or Cold, Reusable", regulation number 21 CFR 890.5700, device class 1.

Both 21 CFR 890.5730 and 21 CFR 890.5700 classify their devices as Class I (general controls) and state that the device is exempt from the premarket notification procedures in subpart E of part 807. There is therefore no 510(k) number for this product, and none is required. Nothing here should be read as a statement of FDA approval or clearance.