Respiratory Products

7625 West New York Street

Indianapolis, Indiana 46214-4911 USA

Phone: (317) 273-6960 Fax: (317) 273-6979
Order Desk Telephone: (800) 401-1723
To contact Flotec's Customer Service Department, email orderdesk@floteco2.com
To contact Flotec's Regulatory Department, email qa@floteco2.com
To provide feedback to Flotec, use our survey.

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Certificates & Licenses

Australian GMDN 31283 Declaration of Conformity, Flowmeter, Gas, Calibration
Australian GMDN 35300 Declaration of Conformity, Regulator, Gas, High-Pressure
Australian GMDN 37132 Declaration of Conformity, Flowmeter, Oxygen Therapy
Australian TGA 144630 Certificate for Inclusion of a Medical Device
Australian TGA and Health Canada, Memorandum of Understanding
EU Authorized Representative MDSS CE Registration Annex A (2017-12-20)
Canada Declaration of Conformity
Canadian Medical Device License 2018 Renewal
Canadian Medical Device License, Flopac Integrated Valve Regulators 73462
Canadian Medical Device License, Flowmeter 28175
Canadian Medical Device License, Gas Regulators  8347
Canadian Medical Device License, Oxysavrr Conserving Regulator  28176
Canadian Medical Device License, Hose Assembly - Canadian Standard  105590
Declaration of Conformity - EU
CE Mark 1434 Full Quality Assurance System Approval (Page 1)
CE Mark 1434 Full Quality Assurance System Approval (Page 2)
FDA Registration
FDA European and Canadian Device Classification Cross Reference
FDA Small Business Qualification Certificate
ISO 13485:2016 Certificate of Registration
MDSAP Certificate of Registration
Japanese Medical Device License: BG30400412
Japanese Quality Agreement
Military Critical Technical Data Agreement
RoHS 3 Declaration of Conformity