Applied Silicone's MDM Fluid was designed as a substitute for Dow Corning Medical Grade 360 Fluid.  Applied's MDM Fluids are pure, clear colorless polydimethylsiloxane.  They are available in standard viscosities of 350 and 12,500 cps.  These fluids are ideal for lubrication of critical medical devices.  MDM is soluble in a variety of aliphatic, aromatic, chlorinated and oxygenated solvents and is compatible with many pharmaceutical, cosmetic and medical device preparations.

Special features include:
· High purity
· Chemical inertness
· High water repellency
· Low volatility
· Low surface tension
· Low order of toxicity and skin sensitization
· Resistance to decomposition by heat and oxidation
· Good lubrication characteristics for plastics and rubbers

This material is intended for long term implant applications and was designed and tested to meet many of the ISO 10993 requirements.  A sample from each manufactured lot is subjected to an MEM Tissue Culture test.  Additional testing is available by request.

Manufacturing of this product is performed under stringent quality control and is fully traceable per ISO 9001 certified procedures.  An FDA Master File reference including formulation, manufacturing methods, testing and toxicology is available.

The users must carefully review literature for uses where adverse effects are reported for certain applications of silicone in medical devices.  The users of this material must independently determine that any product that any product incorporating this material is safe and effective.

MDM Fluid is intended for use in a variety of medical applications including: lubricant for plastic or rubber devices and instruments, inert protective coating and water repellent film on the skin, and a hydrophobic surface on glass and ceramic substrates.

MDM Fluid can be applied to the barrels of plastic syringes to insure smooth operation of the plunger.  It may also be used to lubricate rubber or plastic tubes and metal instruments that are inserted into the body.  MDM Fluid is recommended for application to hypodermic needles to allow easy insertion and is ideal for lubricating instruments to permit easier movement of the instrument and to minimize injury to body tissue.  MDM Fluid may be used in conjunction with Applied Silicone's 40097 RTV Silicone Lubricant for adherent thin, lubricant release coatings used in applications such as hypodermic needles and scalpel blades.

MDM Fluid can be used as an effective lubricant for the sockets of artificial  limbs and eyes.  It serves as a surface coating on latex urethral catheters to reduce irritation to the urethra.  This product is not a suitable lubricant for repetitive rubbing contact on metals.

MDM Fluid can be used as a condom lubricant.  Films of MDM Fluid transmit water vapor readily, yet are highly repellent to water and water-based fluids.  they can be formulated into effective barrier creams and sprays to protect the skin from water, waterborne irritants and from many solvents.

MDM FLuid is ideal for treating the surfaces of glass, ceramics, enamels, plastics, rubbers, and metals.  The fluid film provides a temporary water repellent, biologically inert barrier over the treated material. This barrier lessens damage to blood and delays its clotting.

MDM Fluid is an effective defoamer for many foaming fluids. both aqueous and nonaqueous.  Applied Silicone also supplies specially formulated defoamers for medical applications requiring high defoaming efficiency.

Each production lot is certified as having passed Cytotoxicity and physical properties.  Other testing is available upon request.

Packaging is available in 8, 40 and 420 pound epoxy lined metal containers.

Suggested retest at twelve months from the date of shipment.

Each production lot is certified as having passed Cytotoxicity and physical properties. Other testing is available upon request.

Revised 10.15.02