REGULATORY

Providing hospitals, nursing homes, home healthcare providers, athletic organizations, and other industry sectors with premier wound dressings, Ferris has successfully designed, developed, manufactured, and distributed its unique PolyMem products for over 20 years.

Ferris has developed a Quality System to meet and exceed the standards and regulations of the U.S., Canada, the European Union, and other countries and organizations of the world. FDA registration, Canadian licensing, MDD 93/42/EEC and ISO 13485: 2003 and EN ISO 13485:2012 certification are maintained to ensure compliance with U.S. and international standards.

Quality Management System

We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations and US FDA Good Manufacturing Practice (GMP).

Notified Body / Registrar / Certification Body

Ferris Mfg. Corp. maintains MDD 93/42/EEC, EN ISO 13485:2012 and CMDCAS ISO 13485:2003 certification and is audited every year. Our Certificates have been issued by:

TÜV Rhineland LGA Products GmbH

Tillystraße 2

90431 Nurnberg, Germany

Phone: +49 221 806-1371

Fax: +49 221 806-3935

Email

Website

Notified Body number: 0197

Product Certifications and Approvals

UNITED STATES

FDA 510(K) Cleared

CANADA

Medical Device Licenses

EUROPE

EC Certificate

AUSTRALIA

Devices listed in ARTG

Global Regulatory Representatives

AUSTRALIA - Sponsor Representative

Emergo Australia, Sydney, Australia

Telephone: +61-2-9006-1662

Website

EUROPE - Authorized European Representative

(Regulatory Information Only)

Emergo Europe, The Hague, Netherlands

Telephone: +31-70-345-8570

Website

DME Jurisdictions and Coding System

Medicare Billing Resources

Reimbursement is complex and changes in policy and coverage criteria occur frequently. It is critical to direct anyone looking for specific reimbursement information beyond the list of approved HCPCs codes to check with their local carrier. Prior to billing any medical supply, each provider should review their regional/jurisdictional DME MAC manual and/or contact their regional/jurisdictional carrier directly to determine coverage criteria specific to the supplies they are billing.

Claims jurisdiction is determined by the state in which the beneficiary permanently resides.

It is Ferris Mfg. Corp. policy not to offer reimbursement advice.

DME MAC Jurisdiction A

(Northeast)

CT, DE, DC, MA, ME, MD, NH, NJ, NY, PA, RI, VT

DME MAC Jurisdiction B

(Midwest)

IL, IN, KY, MI, MN, OH, WI

DME MAC Jurisdiction C

(South/Southwest)

AL, AR, CO, FL, GA, LA, MS, NC, NM, OK, PR, SC, TN, TX, VI, WV, US Virgin Islands

DME MAC Jurisdiction D

(West)

AK, AZ, CA, HI, ID, IA, KS, MO, MT, ND, NE, NV, OR, SD, UT, WA, WY, Am. Samoa, Guam, N. Mariana Islands

DME MAC Jurisdictions

Durable Medical Equipment (DME) Medicare Administrative Contractor (MAC) Jurisdictions

Review Contractor Directory

Interactive Map

CONTACT US

If you have any questions or comments please contact Ferris using one of the following methods.

OUR ADDRESS

Toll Free: (800)POLYMEM (765-9636)

International: +1(817)900-1301

Fax: (817)625-4277

info@polymem.com

www.polymem.com

5133 Northeast Parkway, Fort Worth, TX 76106-1822 U.S.A.