Alden Medical LLC

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Web: http://www.aldenmedical.com
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Address: 360 Cold Spring Ave., West Springfield, Massachusetts 01089, USA
Phone: +1-(800)-742-1990 | Fax: +1-(413)-747-9721 | Map/Directions >>

Profile: Alden Medical LLC provides custom chemical blending needs in the industrial and medical markets. We also offer in-vitro diagnostic solutions, medical grade enzymatic detergents, disinfectant indicators and ampuled products. We specialize in custom blending and contract manufacturing for the medical, dental, water treatment and agricultural industries. We manufacture peracetic acid, glutaraldehyde and high level disinfectants for dialysis, endoscopy and medical/dental instrumentation.

FDA Registration Number: 1221361

8 Products/Services (Click for related suppliers)

• Central Multiple Patient Dialysate Delivery System (FDA Code: FKQ / 876.5820)

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

• Dialysis Standard-Conductivity Solution-Test (FDA Code: FKH / 876.5820)

• Dialyzer Reprocessing System (FDA Code: LIF / 876.5820)

• Disinfectants

• Medical Device, Sterilant (FDA Code: MED / 880.6885)

A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.

• Medical Devices, Disinfectant (FDA Code: LRJ / 880.6890)

A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.

• Physical/Chemical Sterilization Process Indicator (FDA Code: JOJ / 880.2800)

A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.

• Secondary Calibrator (FDA Code: JIT / 862.1150)

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)