7625 West New York Street
Indianapolis, Indiana 46214-4911 USA
Telephone: (317) 273-6960
Facsimile: (317) 273-6979
Order Desk Telephone: (800) 401-1723
Order Desk Facsimile: (800) 515-9254
E-mail: flotec@floteco2.com

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Certificates & Licenses

 

Australian GMDN Code: 31283 - Flowmeter, Gas Calibration, Manufacturer's Declaration of Conformity

Australian GMDN Code: 35300 - Regulator, Gas High-Pressure, Manufacturer's Declaration of Conformity

Australian GMDN Code: 37132 - Flowmeter, Oxygen Therapy, Manufacturer's Declaration of Conformity

Australian Register of Therapeutic Goods - 37132 Flowmeter, Oxygen Therapy, Certificate for Inclusion of a Medical Device

Australian Therapeutic Goods Administration & Health Canada Mutual Recognition of Medical Device QMS Certificates

Canadian Medical Device License: 8347 - Oxygen Regulator (Select License Number and type 8347 in search field)

Canadian Medical Device License: 28175 - Flowmeter (Select License Number and type 28175 in search field)

Canadian Medical Device License: 28176 - Oxygen Conserving Regulator (Select License Number and type 28176 in search field)

Canadian Medical Device License: 73462 - Integrated Valve Regulator (Select License Number and type 73462 in search field)

FDA Establishment Listing for Flotec, Inc. - Establishment Registration Database at Center for Devices and Radiological Health

FDA Annual Registration - Subpart B--Procedures for Device Establishments, Part 807 -- Establishment Registration and Device Listing for Manufacturers 

FDA Certificate to Foreign Government - List of Products that maybe Legally Marketed and Exported from the United States

FDA, European and Canadian Device Classification Cross Reference - Dated 06-19-07, List of Flotec products with cross reference information between the: Code of Federal Regulation, Section 21; European Commision Meddev 2.4/1 Rev 8, Part 2, Rule 11 (Directive 93/42/EEC; Health Canada CAN/CSA-Z305 87M, Part 1, Rule 9

ISO 9001:2000 - Scope of Registration 3841(US): Surgical and Medical Instruments and Apparatus (P-iso9001.2000(1 of 3(06-12-15)).pdf)

ISO 13485:2003 - Scope of Registration 3841(US): Surgical and Medical Instruments and Apparatus  (P-iso13485.2003(2 of 3(06-12-15)).pdf)

ISO 13485:2003 - Scope of Registration (CMDCAS): Surgical and Medical Instruments and Apparatus  (P-iso13485.2003(3 of 3(06-12-15)).pdf)

EC Certificate - Full Quality Assurance - CE mark 0843 (P-UL-EC Certificate(2007a).pdf)
European Authorized Representative - Contact Information for Flotec Authorized Representative
Japanese Medical Device License: BG30400412 - Japanese Medical Device QMS, Ministerial Ordinance No. 169, December 17, 2004
Japanese Quality Agreement - Japanese Ministry of Health, Labour and Welfare Agreement entered into by Flotec and the Marketing Authorization Holder