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The Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a moist healing environment, manage exudate, and protect the wound from contamination. The dressing is indicated for the management of the following types of wounds: Partial and full-thickness wounds, moderate to heavily exudating wounds such as; lower extremity ulcers including; venous stasis ulcers, arterial ulcers, or mixed etiology (venous & arterial) and post surgical incisions, pressure sores, and diabetic foot ulcers. Partial thickness wounds such as; donor sites, abrasions, lacerations, and superficial burns. Other indications include; a drainage dressing for tracheostomy, G-tube, J-tube, Penrose drain, chest tube, or sump drain, as well as a secondary or cover dressing for packed wounds.

The device has not changed from those approved under Bioderm, Inc. K982778 and consist of square, hydrophilic foam pads for wound care and square foam pads with a slit to fit around tracheostomy or gastrostomy tubes. The device provides a means to absorb exudate from draining wounds.

The Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a moist wound healing environment and manage exudate. The dressing is indicated for the local management of the following types of wounds: 1. Partial and full thickness wounds, moderate to heavily exudating wounds such as; a. venous stasis ulcers. b. pressure sores. c. post operative incisions. d. diabetic ulcers. 2. Partial thickness wounds such as; a. abrasions. b. lacerations. c. donor sites. d. superficial burns. 3. Other indications include; a. drainage dressing for tracheostomy and gastrostomy tubs.

Bioderm Foam Wound Dressing

The BioDerm BTF Wound Dressing is a sterile thin film dressing intended for over-the-counter use and prescription use. The BioDerm BTF consists of a transparent, polyurethane film backed with a hypoallergenic pressure sensitive adhesive. The BTF is permeable to moisture vapor and oxygen and intended to maintain a moist wound healing environment. A moist wound environment allows atolytic debridement. OTC Indications for Use: - Abrasions, lacerations, minor/superficial cuts; - Minor scalds, minor burns; - Minor irritations to the skin Under the Care of a Health Care Professional: - Leg ulcers, pressure ulcers (stages I and II); - Surgical wounds (post operative wounds, donor sites); - 1st and 2nd degree burns; - Cover and protect catheter sites and wounds; - Securement of medical appliances; - Catheter securing device; - Dermal lesions: - Non-exuding to minimally exuding wounds

The BioDerm BTF Thin Film Wound Dressing is a sterile thin film dressing which consists of a polyurethane film backed with a hypoallergenic pressure sensitive adhesive. The BTF is a transparent dressing which is permeable to moisture vapor and oxygen and intended to provide a moist wound healing environment to facilitate the normal wound healing process. The BTF Thin Film Wound Dressing provides a barrier to bacteri and external contaminates.

REVISED 1. Venous Stasis Ulcers 2. Pressure Ulcers 3. Diabetic Ulcers 4. Surgical Wounds

Bioderm Calcium Alginate Wound Dressing

- 1. Venous stasis ulcers. - 2. Pressure sores Stages 1, 2, 3, & 4. - 3. Ulcers triggered by trauma. - 4. Drainage dressing for tracheostomy and gastrostomy tubes. - 5. Post operative incisions.

Bioderm Foam wound Dressing

The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag.

BioDerm® EID® MALE EXTERNAL INCONTINENCE DEVICE