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Tracheoesophageal device insertion capsule

Definition
A non-sterile, smooth, capsule-like device intended to house/cover a tracheoesophageal device (e.g., speech valve, fistula gauge) at the distal end of the introduction assembly, to enable atraumatic insertion of the device into the tracheoesophageal fistula (puncture). It is a synthetic polymer gelatinous casing intended to dissolve in situ for subsequent digestion; disposable devices intended to assist mounting may be included. It is intended to be used in the home and healthcare facility, and may be used in conjunction with a lubricant. This is a single-use device.
GUDID devices
25
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07331791009006Provox Capsule 17FrAtos Medical AB77952022-11-23
07331791009013Provox Capsule 20FrAtos Medical AB77962022-11-23
07331791009020Provox Capsule 22.5FrAtos Medical AB77972022-11-23
08904461055697OSSEOUS-CapsuleEON MEDITECH PRIVATE LIMITEDEA9100182026-03-13
08904428798377OSSEOUS-CapsuleEON MEDITECH PRIVATE LIMITEDEA9100182026-03-13
07331791016264Provox Capsule 17FrAtos Medical AB77952022-11-23
07331791016271Provox Capsule 20FrAtos Medical AB77962022-11-23
07331791016288Provox Capsule 22,5FrAtos Medical AB77972022-11-23
00848253001067InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBE 31952016-09-24
00848253001487InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCDV 2008-LF2018-01-01
00848253001500InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCDV 2012-LF2018-01-01
00848253003191InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBE 32952018-03-01
00813307010951InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCDV 2010-NS2018-01-01
00813307010975InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCDV 2014-NS2018-01-01
00813307011477InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLP 31002017-01-01
00813307011491InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBE 31902016-09-24
00813307011507InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBE 32902016-09-24
00813307012573InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBE 6039-P2018-01-01
00813307014409InHealth Technologies; Blom-SingerFreudenberg Medical, LLCIN 1604-LETO2018-01-01
00813307014416InHealth Technologies; Blom-SingerFreudenberg Medical, LLCIN 2006-LETO2018-01-01
00813307014423InHealth Technologies; Blom-SingerFreudenberg Medical, LLCIN 1606-LETO2018-01-01
00813307014454InHealth Technologies; Blom-SingerFreudenberg Medical, LLCIN 2010-LETO2018-01-01
00813307014461InHealth Technologies; Blom-SingerFreudenberg Medical, LLCIN 1610-LETO2018-01-01
00813307014492InHealth Technologies; Blom-SingerFreudenberg Medical, LLCIN 2014-LETO2018-01-01
00813307014508InHealth Technologies; Blom-SingerFreudenberg Medical, LLCIN 1614-LETO2018-01-01