Issue Stories

Manufacturing News

 Impact Achieves Certification
Impact Instrumentation Inc, West Caldwell, NJ, announces its recent assessment by Orion Registrar and that it was found to be in compliance with the ISO 9001:1994 Quality System Standards, EN460001:1996 and ISO 13485:1996. Certification was achieved by the company’s quality management team, which was led by Alan Giordano, regulatory affairs manager.

Impact’s quality management system certification applies to the design, manufacture, service, and distribution of the company’s portable ventilators, automatic resuscitator/ventilators, suction apparatus (including portable, mobile, in-wall, and on-board units), vacuum pumps, compressors, and rail mounting systems. The system is designed to assure that product quality meets or exceeds the requirements and expectations of Impact’s customers. The system also includes controls for the prevention of nonconformities, early detection of discrepancies, and corrective action to assure consistent delivery of quality products. www.impactinstrumentation.com.


 Abbott Launches Web Site
Customers of Abbott Diagnostics, Abbott Park, Ill, will now be able to access the Web site e-abbott.com to check on the status of existing orders and place new ones directly into the company’s order system. An e-abbott help desk has been established to answer questions by phone, and the site will give users 24-hour access to inquiries about standing orders, real-time shipping status, customized order templates, and a choice of delivery options. Customers can browse the company’s catalog and review invoices. Abbott Laboratories develops, manufactures, and markets health care products and services globally, and its offerings span prevention, diagnosis, treatment, and cure. www.e-abbott.com.


FDA Clears CHAD Oxygen Conserver
CHAD Therapeutics Inc, Chatsworth, Calif, announces its recent receipt of US Food and Drug Administration (FDA) clearance to market the CYPRESS™ OXYPneumatic® oxygen conserver, the company’s first nonelectronic conserver. The introduction of this new product is part of the company’s expansion of its oxygen conserving product line, intended to provide home medical equipment providers with optimal choices to address individual needs, preferences, and disease conditions. Lightweight and small, the CYPRESS needs no batteries and can be used with a single-lumen cannula. www.chadtherapeutics.com.


PARI Parent Company Named Among 10 Best
PRE Holding Inc, Midlothian, Va, parent company of PARI Respiratory Equipment Inc, Monterey, Calif, manufactures aerosol delivery products for patients with respiratory diseases. PRE Holding was recently selected from more than 1,000 nominations and named one of the 10 best US companies for its employee and financial benefits program. Together with an independent panel of judges, The Principal Financial Group honored PRE for its comprehensive benefits program and for the outstanding communication methods. www.pari.com.

Nellcor Receives Design Award
Nellcor, part of Tyco Healthcare, Pleasan-ton, Calif, announces that the Nellcor OxiFirst Fetal Pulse Oximetry System was granted Gold Status at the 2002 Medical Design Excellence Awards Ceremony, held in New York in conjunction with the Medical Design & Manufacturing East Conference and Exposition. Since the US commercial launch of the product in May 2000, more than 485 OxiFirst Fetal Pulse Oximeters have been installed in hospitals across the country. www.nellcor.com

Schiller Reveals new Diagnostic testing
SCHILLER America, Miami, introduces the combination of its CARDIOVIT CS-200 Ergo-Spiro with pulmonary function diagnostic technology. With the multifunctional exercise testing system for cardiology, pneumology, and sport and industrial medicine, a physician can gather all data for a complete diagnosis. Cardiopulmonary exercise testing, metabolics, and ECG are recorded simultaneously, and breath-by-breath analysis is calculated by a high-speed gas analyzer according to individual parameters. Two monitors enable direct real-time visual comparison of the ECG, exercise test data, and gas values. www.schiller.ch

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