Custom Ultrasonics, Inc.

Address: 144 Railroad Drive, Ivyland, Pennsylvania 18974, USA
Phone: +001-(215)-364-8577 | Fax: +001-(215)-364-7674 | Map/Directions >>

Profile: Custom Ultrasonic, Inc. provides systems that automatically clean and disinfect flexible endoscopes. We serve hospitals, outpatient clinics, ambulatory centers and physician offices. Some of our product names are System 83 Plus 2, System 83 Plus 9, S-6 & S-8 pre-processing sinks, and System 83™ storage cabinets. The System 83™ storage cabinet is fabricated of painted steel to provide an environment for storage of endoscopes, that is free of absorbent material to discourage bacterial and fungal growth. It is designed to accommodate up to eight endoscopes. A gasket surrounds the door opening. When the door is closed, the gasket is compressed providing a sealed enclosure. There is an enclosure at the top that contains an air pump for the circulation of dehumidified air through the channels. Preceding the air pump, it contains desiccant bags, which remove the moisture from the re-circulated air. A series of openings, located beneath the desiccant, allow for air movement through a door opening. The System 83 Plus is the only automated ultrasonic washer/disinfector for reprocessing flexible endoscopes. The wash, high-level disinfect and rinse process has been standardized and validated for consistent reprocessing of flexible endoscopes. For infection Control, the system is compatible with virtually all approved liquid chemical sterilants.

The company has ~20 employees and is CE certified.

FDA Registration Number: 3007082252

14 Products/Services (Click for related suppliers)  
• Disinfectant Transfer System
• Disinfectors
• Dry/Lock Storage Cabinet
• Dual Chamber Washer/Disinfector
• Endoscope Accessories (FDA Code: KOG)
• Endoscope Sterilizer/Washer (Flexible, Sanitizer, Processor, Rigid, Cleaner, Disinfector)
• Endoscope Storage Cabinet
• Endoscopic Cleaning Accessories (FDA Code: FEB / 876.1500)
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
• Fume Recovery Filters
• Medical Instrument Ultrasonic Cleaner (FDA Code: FLG / 880.6150)
An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves.
• Personal Environmental Contamination Monitor
• Pre-Processing Sink
• Respiratory/Anesthesia Equipment Washer
• Single Chamber Washer/Disinfector

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