Bruder Moist Heat Eye Compress, Microwave Activated, Reusable

About the Product

A reusable fabric eye compress that is heated in a microwave and applied over the closed eyes. It is contoured to fit over both eyes and has an adjustable strap, though it can also be used without the strap. The compress 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. The mask is latex free, and completely hand washable and reusable, so no cover is required.

People buy this as a reusable warm compress for a daily eyelid routine. It is warmed in the microwave and worn over the closed eyes for 8 to 10 minutes at a time, once or twice a day or as directed by an eye care professional. Because the beads take their moisture from the air, the same compress is washed and used again rather than replaced after each use.

Materials

• MediBeads fill Specially formed and treated 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 hand washable fabric that encloses the beads and holds the contoured shape worn over the closed eyes, so no separate cover is required.
• Adjustable strap The strap that holds the compress in position over the eyes, which can be left off if preferred.

What Is Included

• One Bruder Moist Heat Eye Compress with adjustable strap, packaged as a single mask in a polybag.

Specifications

How to Use

1. Before heating, place compress on a microwave safe plate to keep it clean.
2. Set plate on the rotating tray and microwave for 20 seconds. To increase heat, warm in additional 5 second increments. Do not exceed 30 seconds total.
3. Touch test compress before placing over eyes. If the compress feels too hot, remove immediately and wait 1 to 2 minutes before reapplying.
4. Apply for 8 to 10 minutes over closed eyes or as prescribed by your doctor.
5. If reused within 30 minutes, reduce heating time by half.

Care and Cleaning

• Before washing, wait 2 hours after use.
• Hand wash only in cold water with a mild detergent.
• Air dry for at least 24 hours before use.
• Wash if exposed to makeup, creams, oils, grease or food.
• If using daily, consider replacing after 6 months.

Warnings

• Remove racks and shelves from microwave prior to heating.
• Do not exceed 30 seconds total heating time.
• Touch test compress before placing over eyes. If the compress feels too hot, remove immediately and wait 1 to 2 minutes before reapplying.
• Compress should not be applied tightly and can be used without the strap if desired.
• After treatment, you may experience blurry vision that will clear in a few minutes as your tear glands are releasing beneficial fluids.

Regulatory

This product is listed with the FDA under establishment registration number 1039131, held by The Hilsinger Company Parent, LLC of 575 West Street, Suite 120, Mansfield, MA 02048. The registered establishment is Bruder Healthcare Company, 9240 Seward Rd, Fairfield, OH 45014.

The registration covers this product under two product codes: IMA, device name "Pack, Heat, Moist", regulation number 21 CFR 890.5730, and IME, device name "Pack, Hot Or Cold, Reusable", regulation number 21 CFR 890.5700. As a moist heat pack, 21 CFR 890.5730 is the applicable regulation. Both are device class 1.

Devices classified under 21 CFR 890.5730 are Class I and are exempt from the premarket notification procedures in subpart E of part 807, subject to the limitations in 21 CFR 890.9. 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.