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 follow up on or to place orders: orderdesk@floteo2.com
For Flotec's Purchasing Department: purchasing@floteco2.com
For Flotec's Accounts Payable Department: accountspayable@floteco2.com
For Flotec's Accounts Receivable Department: accountsreceivable@floteco2.com

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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 120152 Certificate for Inclusion of a Medical Device
Australian TGA and Health Canada, Memorandum of Understanding
Authorized Representative MDSS CE Registration Annex A (2017-12-20)
Canada Medical Device License, Flopac Integrated Valve Regulators 73462
Canada Medical Device License, Flowmeter 28175
Canada Medical Device License, Gas Regulators  8347
Canada Medical Device License, Oxysavrr Conserving Regulator  28176
CE Mark 0843 Full Quality Assurance System Approval Certificate
FDA Certificate to Foreign Government (2014-09-09- thru 2016-09-08)
FDA 2014 Registration
● FDA 2014 Device Listing, Cannula, Nasal, Oxygen
● FDA 2014 Device Listing, Conserver, Oxygen, Oxysavrr
● FDA 2014 Device Listing, Flowmeter, Calibration, Gas
● FDA 2014 Device Listing, Regulator, Pressure, Gas Cylinder
FDA European and Canadian Device Classification Cross Reference
FDA Small Business Qualification Certificate
ISO Declaration of Conformity
ISO 13485:2003 / Cor 1:2009 EN ISO 13485:2012
Certificate of Registration
ISO 13485-03 Certificate of Registration
Japanese Medical Device License: BG30400412
Japanese Quality Agreement
Military Critical Technical Data Agreement
Notified Body Product Listing Modification (2015-04-23)