FDA.reportPublic FDA data

Tracheoesophageal device introducer

Definition
A non-sterile, hand-held manual instrument designed to assist in the non-surgical placement of a tracheoesophageal device (e.g., speech valve, speech valve occluder, fistula gauge/dilator). It is a synthetic polymer holder onto which the tracheoesophageal device is distally mounted and directed to the target site through the tracheostoma. It is intended to be used by the patient at home (for non-indwelling devices) and clinician in the healthcare facility (for indwelling devices). This is a single-use device.
GUDID devices
49
Last updated
2019-03-30 12:04:59

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00813307010647InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCAS 1604-NS2018-01-01
00813307010661InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCAS 1608-NS2018-01-01
00813307010685InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCAS 1612-NS2018-01-01
00813307010746InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCAS 2004-NS2018-01-01
00813307010760InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCAS 2008-NS2018-01-01
00813307010784InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCAS 2012-NS2018-01-01
00813307010845InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCAD 2004-NS2018-01-01
00813307010869InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCAD 2008-NS2018-01-01
00813307010883InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCAD 2012-NS2018-01-01
00813307010982InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1608-SO2018-01-01
00813307011002InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1612-SO2018-01-01
00813307011026InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2008-SO2018-01-01
00813307011040InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2012-SO2018-01-01
00813307011064InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1604-NS2017-01-01
00813307011088InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1608-NS2017-01-01
00813307011101InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1612-NS2017-01-01
00813307011118InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1614-NS2017-01-01
00813307011132InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1618-NS2017-01-01
00813307011170InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2006-NS2017-01-01
00813307011194InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2010-NS2017-01-01
00813307011217InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2014-NS2017-01-01
00813307011231InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2018-NS2017-01-01
00813307011262InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2004-LEF2018-01-01
00813307011293InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2008-LEF2018-01-01
00813307011316InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2012-LEF2018-01-01
00813307011347InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2007-SL2018-01-01
00813307011392InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2006-IR2018-01-01
00813307011415InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2010-IR 2018-01-01
00813307011590InHealth Technologies; Blom-SingerFreudenberg Medical, LLCIN 40692016-09-24
00813307011613InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBK 41002016-09-24
00813307013853InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1605-SL2018-01-01
00813307013877InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1609-SL2018-01-01
00813307013907InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2005-LESL2018-01-01
00813307013914InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1605-LESL2018-01-01
00813307014102InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1604-LEF2018-01-01
00813307014126InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1608-LEF2018-01-01
00813307014140InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1612-LEF2018-01-01
00813307014164InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2004-LF2018-01-01
00813307014171InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1604-LF2018-01-01
00813307014201InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2008-LF2018-01-01
00813307014218InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1608-LF2018-01-01
00813307014249InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2012-LF2018-01-01
00813307014256InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1612-LF2018-01-01
00813307014294InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1604-LEIR2018-01-01
00813307014300InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 2006-LEIR2018-01-01
00813307014324InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1608-LEIR2018-01-01
00813307014522InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1606-IR2018-01-01
00813307014560InHealth Technologies; Blom-Singer; ClassicFreudenberg Medical, LLCIN 1610-IR2018-01-01
00813307014713InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCDV 2006-NS2018-01-01