Search Results

This device is used as a physical barrier for mouth to mouth resuscitation The use of this device does not guarantee complete protection from disease transmission.

The CPR Shield with One Way Valve and Barrier Filter, Model 4921 is a mouth to mouth barrier that offers protection to the person performing CPR to a patient from vomitus and oral secretions. The device is to be used by persons trained in CPR techniques. The device is labeled as a single use device and should be disposed of after one use. The CPR Shield includes a one-way valve that directs the breathing gas flow from the CPR administrator to the patient, and directed the exhaled gases away from the rescuer and into the atmosphere.

This device is used to expose the interior of the vagina.

The Dynarex vaginal speculum is a non-metal (polystyrene), non-lubricated, hand held device used to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.

The Dynarex Iodoform Packing Strip is a device used as an antibacterial barrier and for general use in wound packing and management. This Iodoform Packing Strip is indicated for external use only.

The Dynarex lodoform Packing Strip is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex lodoform Packing Strip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively. The Dynarex lodoform Packing Strip is a device for general use in wound packing and management and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured.

The Dynarex Towel Drape is a device consisting of natural or synthetic materials intended to be used as a patient covering during General Surgical Procedures.

The Dynarex Towel Drape is composed of nonwoven fabric or polyethylene film and are of various configurations appropriate for General Surgical procedures. These devices use nonwoven and film materials as a protective patient covering during surgical procedures. These barrier materials are essentially impervious to fluids and microorganisms, thus function to isolate the operative site from the surrounding area. Dynarex Towel Drapes may feature tape adhesive to temporarily bind the drape to the periphery of the operative site. Fluid collection pouches are attached to the drape for collection of operative wound solid and liquid effluents. The Dynarex Towel Drape will be subjected to a sterilizing dose of gamma irradiation to achieve a Sterility Assurance Level (SAL) of 10-6. This towel drape is a single use, disposable provided in a sterile package.

The Dynarex Umbilical Cord Clamp is a device used to compress the umbilical cord. Federal (USA) law restricts this device to sale by or on the order of a physician.

The Dynarex Umbilical Cord Clamp instrument is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex Umbilical Cord Clamp is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively.

Non-woven dressing with pre-cut fenestration for use around tracheostomy or IV tubes to absorb exudate and absorb fluids.

Sterile Drain Sponges

Non-Woven sponge for wound dressing prepping and scrubbing.

Non-Woven Sponge, Sterile

A Dressing for use around any tracheostomy or IV tube to absorb exudate, protect against chafing and absorb excess fluids.

Tracheostomy Sponge