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Click here to see the 79 Equipment Listings matching 'CUSTOM ULTRASONICS INC 83 PLUS 9 Ultrasonic Cleaner' on DOTmed

A la venta CUSTOM ULTRASONICS INC 83 PLUS 9 Ultrasonic Cleaner

LISTING #2695767
  • Condition:
  • New
  • Date updated:
  • July 11, 2018
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Specifications for CUSTOM ULTRASONICS INC 83 PLUS 9 Ultrasonic Cleaner

MPN: System 83

Item Summary for CUSTOM ULTRASONICS INC 83 PLUS 9 Ultrasonic Cleaner

The unit has some exterior damage. (1) One left side clear plexiglass acrylic hatch is cracked and needs to be replaced.(2) Right rear door is dented in. (3) Front left door has to be put back on hinge. (4) Right front door needs to be bent back to be aligned. Was purchased in 2009 but has never been used. The item is UNUSED.
Your are more than welcome to come and inspect the unit before purchase or local pick up
after purchase !

Free Standard shipping to Lower 48 contiguous US only !

Warning: This device is not indicated for the reprocessing of duodenoscopes. Do not reprocess any duodenoscopes in this device until further notice. For alternative reprocessing options, please contact the duodenoscope manufacturer.

Custom Ultrasonics Washer-Disinfectors are stand-alone ultrasonic reporcessors that wash and high-level disinfect immersible heat-sensitive endoscopes and components. The wash, high-level disinfect and rinse process has been standardized and validated for consistent reprocessing of flexible endoscopes.

In order to account for all channels of the flexible instrument and all internal surfaces are contacted during cleaning and high level disinfection, System 83 plus adapts to each channel individually making it easier for the technician to verify flow and avoids bifurcating the tubing. This prevents liquid and air from taking the path of least resistance during the process, which ensures a successful outcome.

19" Stainless Steel Processing Chamber
Alcohol Flushing of Channels
Automatic Detergent Injection
Disinfectant Fume Control
Custom Adapter Package
Individual Channel Monitoring
Disinfectant Transfer System
Chamber Access Port

June 14, 2017

Re: Custom Ultrasonics, Inc. Receives Resumption of Manufacturing Letter from FDA

During the week of April 24, 2017, the Food and Drug Administration (FDA) conducted an inspection at Custom Ultrasonics’ manufacturing facility in Ivyland PA. As a result of the inspection and extensive new validation testing of the System 83 Plus™, the FDA has reinstated the manufacturing, packing, and distribution of the System 83 Plus™ Washer/Disinfector (including components and systems) for use in the reprocessing of flexible endoscopes that are not duodenoscopes as of June 12, 2017.

The FDA required Custom Ultrasonics to perform validation testing on the System 83 Plus™, water filtration system and the inline disc filter. These filters were tested by independent laboratories and the performance data was reviewed and accepted by the FDA, with no changes in design. New validations were also requested on reprocessing bronchoscopes and non-GI endoscopes using the System 83 Plus™. Validations were conducted using an FDA approved protocol representing worst-case conditions. All validations met the defined performance criteria. The validations were completed using ortho-Phthalaldehyde high-level disinfectant (OPA) and Tergal 800 detergent. This new, stringent FDA approved protocol met the same strict standards the FDA has required of other automated endoscope reprocessor (AER) manufacturers.

While Custom Ultrasonics continues to work with the FDA to validate the System 83 Plus™ for duodenoscopes, the company continues to warn against the reprocessing of duodenoscopes in the System 83 Plus™ Washer/Disinfector until further notice.

Custom Ultrasonics has undergone many changes in the past several years. The leadership of our new President and CEO has taken Custom Ultrasonics into a new era of progress. Custom Ultrasonics has significantly expanded its Quality, Regulatory and Engineering Departments, as evidenced by the company passing a recent inspection of its facility and quality system with no Form 483s, in preparation for Custom Ultrasonics’ re-entry into the automated endoscope reprocessing market and beyond. For over 30 years, Custom Ultrasonics has been a pioneer in the AER market, and under the guidance of our President and CEO, Custom Ultrasonics will continue in that role.

Custom Ultrasonics will be disseminating additional information in the near future as we resume manufacturing the System 83 Plus™ Washer/Disinfector.

Custom Ultrasonics, Inc.

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