About VORTRAN

MISSION


To be the worldwide leader of fully automatic, disposable respiratory medical devices that will provide superior quality, cost-effective treatments and positive clinical outcomes.

THE COMPANY


VORTRAN Medical Technology 1, Inc. has engaged in an extensive research and development process to create the Pulmonary Modulation Technology (PMT), and an associated new line of fully automatic disposable respiratory devices for treating patients with pulmonary diseases in the hospital and alternate site (EMS, post-acute, homecare) market segments.



STATEMENT OF COMPLIANCE


VORTRAN Medical Technology1, Inc. is registered with the U.S. Federal Food and Drug Administration (FDA) and the California State Food and Drug Branch (FDB) as a medical device manufacturer. Annual audits by both the FDA and FDB ensure compliance with “Current Good Manufacturing Practice” (CGMP, 21 C.F.R. Code of Federal Regulation) and the Safe Medical Devices Act of 1990. The design of our devices is reviewed by the FDA as required by the 21 C.F.R. Section 510(k) to ensure that our devices are safe and efficacious. Consistent product quality is assured through our comprehensive Quality Assurance Program certified under ISO 13485:2003. Our goal is to exceed our customers’ expectations and to provide products and service of the highest quality.



QUALITY POLICY


VORTRAN Medical Technology 1, Inc. is dedicated to achieving and sustaining consistent quality through the design and manufacturing of products that meet the needs of the worldwide medical market and the expectations of our customers.

Our objectives will be achieved through…

  • Continuous improvements in an enhanced quality system and the team work of employees and distributors.
  • Implementing and following a quality management system that meets the requirements of ISO 13485 in order to comply with customer requirements.
  • Commitment to meeting applicable national and regional regulatory requirements.
  • Communication of this policy to employees.
  • Reviewing quality objectives and implementing improvements.

wong

Gordon A. Wong, M.D., FCCP,FACP President and Chairman of the Board


SHELF LIFE STATEMENT


Unless otherwise indicated, the shelf life for our disposable product(s) is five (5) years from the date of manufacture when stored under the specified environmental conditions.


MATERIALS STATEMENT


VORTRAN Medical Technology 1, Inc. manufactures respiratory medical products and is committed to meeting all regulatory requirements to achieve the highest quality. All of our products are manufactured in Sacramento, California, USA under strict quality control guidelines. We use only the best materials available to ensure your satisfaction. Our products are produced from certified latex-free materials of the highest quality molded and/or extruded medical grade thermoplastic resin available, such as high density polyethylene, styrene-butadiene copolymers, flexible PVC, silicon rubber, and SS302 stainless steel spring(s).

According to the vendor of the flexible PVC used in the oxygen supply tubing, the exudation one may experience is a natural phenomenon that occurs with all flexible vinyl compounds. When exposed to high temperatures, high humidity, or sunlight, the plasticizers present in the tubing, can migrate to the surface of the tubing, creating an oily film. This film does not indicate a harmful degradation or breakdown of the product. These conditions can also cause discoloration or stiffness in the product. The vendor states that proper stock rotation, using a “First In First Out” process, will minimize the likelihood of exposure to such environmental conditions. High heat, humidity and prolonged exposure to intense ultraviolet light will not cause an inability of the tubing to perform but could cause a loss of cosmetic quality.

WARRANTY STATEMENT


VORTRAN Medical Technology 1, Inc. warrants that each new product or parts thereof will be free of defects in workmanship or materials. Should any failure to conform to this warranty appears with substantiation that the product has been stored, installed, maintained and operated in accordance with manufacturer’s instructions and standard industry practice, and that no modifications, substitutions or alterations have been made to the product, VORTRAN Medical shall correct such defect by suitable repair or replacement. Any misuse of the products or parts thereof may void the warranty. All warranty decisions are made by the manufacturer.



CUSTOMER SERVICE


VORTRAN Medical Technology 1, Inc. is committed to providing our customers with the highest level of service and support. If you have a specific question or concern, please contact us directly via email at info@vortran.com, or by phone at (800) 434-4034, or by fax (916) 648-9751.

Our knowledgeable Customer Service team can provide answers or clarification to the following product and company inquiries:


SERVICE & SUPPORT:

  • Technical Support
  • Order Status
  • Partial Shipments and Special Orders
  • Problems or Complaints
  • Refurbishment or Repair Services
  • Product Warranty Procedures

mccarthy

Jody McCarthy, Vice President, Sales and Marketing
jmccarthy@vortran.com


RETURN GOODS POLICY


All returns must be accompanied by a Returned Goods Authorization (RGA) number. To obtain RGA number, contact Customer Service at (800) 434-4034.

The following information is needed to request an authorization:

  • Reason for return
  • Date of purchase
  • Invoice or PO number
  • Product order and control number
  • Quantity to return

All authorized returns must be made within sixty (60) days of the invoice date and be accompanied by the appropriate purchase order number and RGA number.


ALLOWABLE SCHEDULE FOR AUTHORIZED RETURN


  • Orders processed in error by VORTRAN Medical will be credited in full
  • Defective products will be credited in full
  • Unless defective or shipped in error, any return accepted is subject to a 15% restocking fee (minimum charge of $10.00)
  • All returned products are subject to VORTRAN Medical’s inspection and acceptance
  • Product must be shipped prepaid

NON-RETURNABLE, OTHER THAN FOR A MANUFACTURING DEFECT


  • Products discontinued by VORTRAN Medical
  • Products engraved, etched or labeled
    by hospital
  • Returns more than sixty (60) days past
    invoice date
  • Custom, special or modified products
  • Disposable products
  • Products damaged beyond repair, refurbishment or not in resalable condition