FDA.reportPublic FDA data

Tracheostomy tube neck holder, single-use

Definition
A non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a single-use device.
GUDID devices
283
Last updated
2026-09-29 04:01:58

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00848530062194Tracheostomy Tube Neckband with Fastener Tabs - AdultSunset Healthcare Solutions, Inc.RES0292018-07-31
00848530062200Tracheostomy Tube Neckband with Fastener Tabs - PediatricSunset Healthcare Solutions, Inc.RES029P2018-07-31
00848530062231Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - AdultSunset Healthcare Solutions, Inc.RES0302018-07-31
00848530062248Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - PediatricSunset Healthcare Solutions, Inc.RES030P2018-07-31
00848530103514One Piece Tracheostomy Tie Adult 2.5cm x 43cm (17in)Sunset Healthcare Solutions, Inc.RES029-172024-03-20
00848530103521One Piece Tracheostomy Tie Pediatric 2.5cm x 30cm (11.5in)Sunset Healthcare Solutions, Inc.RES029P-112024-03-20
00848530103538Two Piece Tracheostomy Tie Adult 2.5cm x 51cm (20in)Sunset Healthcare Solutions, Inc.RES030-202024-03-20
00848530103545Two Piece Tracheostomy Tie Pediatric 2cm x 25.5cm (10in)Sunset Healthcare Solutions, Inc.RES030P-102024-03-20
00848530103552Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in)Sunset Healthcare Solutions, Inc.RES030P-142024-03-20
00848530103569Two Piece Tracheostomy Tie Pediatric 2cm x 45.5cm (18in)Sunset Healthcare Solutions, Inc.RES030P-182024-03-20
00840117312326Resp-O2 Breathable-Foam Trach Tube Holder, 1PC, Neck 9-14"/23-35 cmDynarex Corporation350312022-05-14
00840117312333Resp-O2 Breathable-Foam Trach Tube Holder, 1 PC, Neck 11-17"/28-43 cmDynarex Corporation350322022-05-14
00840117319233Resp-O2 Comfort-Foam Trach Tube Holder, 1PC, Neck 9"-14"/23-35 cmDynarex Corporation350252022-05-11
00840117319240Resp-O2 Comfort-Foam Trach Tube Holder, 1 PC, Neck 13"-19"/ 33-48 cmDynarex Corporation350262022-05-11
00840117319257Resp-O2 Comfort-Foam Trach Tube Holder, 2PC, Maximum Neck Size 9"/23 cmDynarex Corporation350272022-05-14
00840117319264Resp-O2 Comfort-Foam Trach Tube Holder, 2 PC, Maximum Neck Size 18"/46 cmDynarex Corporation350282022-05-14
00840117319271Resp-O2 Comfort-Foam Trach Tube Holder, 2 PC, Maximum Neck Size 19.5"/50 cmDynarex Corporation350292022-05-14
00840117319288Resp-O2 Comfort-Foam Trach Tube Holder, 2 PC, Maximum Neck Size 28"/71 cmDynarex Corporation350302022-05-14
00840117319394Resp-O2 Breathable-Foam Trach Tube Holder,1PC, Neck 13-19"/33-48 cmDynarex Corporation350332022-05-14
00840117319400Resp-O2 Breathable-Foam Trach Tube Holder, 2 PC, Maximum Neck Size 19.5"/50 cmDynarex Corporation350342022-05-14
00840117319417Resp-O2 Soft-Foam Trach Tube Holder, 1PC, 13.22" LengthDynarex Corporation350352022-05-14
00840117319424Resp-O2 Soft-Foam Trach Tube Holder, 1PC, 15.25" LengthDynarex Corporation350362022-05-14
00840117319431Resp-O2 Soft-Foam Trach Tube Holder, 1PC, 22" LengthDynarex Corporation350372022-05-14
00840117312296Resp-O2 Comfort-Foam Trach Tube Holder, 1 PC, Neck 7"-9"/ 18-23 cmDynarex Corporation350202022-05-11
00840117312302Resp-O2 Comfort-Foam Trach Tube Holder, 1 PC, Neck 9"-14"/23-35 cmDynarex Corporation350212022-05-11
00840117312319Resp-O2 Comfort-Form Trach Tube Holder,1 PC,Adult,Neck 13"-19"/33-48 cmDynarex Corporation350222022-05-11
00840117319219Resp-O2 Comfort-Foam Trach Tube Holder,1 PC, Neck 16-24"/41-61 cmDynarex Corporation350232022-05-11
00840117319226Resp-O2 Comfort-Foam Trach Tube Holder, 1PC, Neck 7-9"/18-23 cmDynarex Corporation350242022-05-11
04719874958282Create BiotechCREATE BIOTECH CO., LTD.019-007-0042026-07-21
15019517382518ICU Medical, Inc.ICU MEDICAL, INC.011-100/503/2002026-06-01
00612479280571McKessonMCKESSON MEDICAL-SURGICAL INC.16-4402026-01-26
00612479280601McKessonMCKESSON MEDICAL-SURGICAL INC.16-4412026-01-26
00612479280632McKessonMCKESSON MEDICAL-SURGICAL INC.16-4422026-01-26
00612479280663McKessonMCKESSON MEDICAL-SURGICAL INC.16-4442026-01-26
00817213020844NATIONAL HOSPITAL PACKAGINGSurgi-Pak, Inc.19-001 NS12022-12-05
00850014574031Trach TiePEPPER MEDICAL INC.V3012020-04-17
00850014574079Vent TiePEPPER MEDICAL INC.401P2020-04-17
00850014574109Vent TiePEPPER MEDICAL INC.4052020-04-17
00850014574116Trach TiePEPPER MEDICAL INC.V5012020-04-17
00850014574147Pedi TiePEPPER MEDICAL INC.V501P2020-04-17
00850014574161Vent TiePEPPER MEDICAL INC.405W-White2020-04-17
00850014574178Vent TiePEPPER MEDICAL INC.406B-Blue2020-04-17
00850014574215Trach TiePEPPER MEDICAL INC.10012020-04-17
00850014574321Trach TiePEPPER MEDICAL INC.V5402020-04-17
00850014574338Trach TiePEPPER MEDICAL INC.V5422020-04-17
00850014574345Trach TiePEPPER MEDICAL INC.302S2020-04-17
00850014574352Trach TiePEPPER MEDICAL INC.302M2020-04-17
00850014574369Trach TiePEPPER MEDICAL INC.302L2020-04-17
00850014574376Trach TiePEPPER MEDICAL INC.504T2020-04-17
00850014574383Trach TiePEPPER MEDICAL INC.540W2020-04-17
00850014574390Vent TiePEPPER MEDICAL INC.440W2020-04-17
00850014574406Trach TiePEPPER MEDICAL INC.5022020-04-17
00850014574413Trach TiePEPPER MEDICAL INC.502P2020-04-17
00850043061007Dr ZeeResp Devices LLC80002022-11-01
00850043061014Dr ZeeResp Devices LLC80012022-11-01
00850043061021Dr ZeeResp Devices LLC80022022-11-01
00850043061038Dr ZeeResp Devices LLC80032022-11-01
00850043061045Dr ZeeResp Devices LLC80052022-11-01
00850043061052Dr ZeeResp Devices LLC80062022-11-01
00850043061069Dr ZeeResp Devices LLC80152022-11-01
00850043061076Dr ZeeResp Devices LLC80162022-11-01
00850043061083Dr ZeeResp Devices LLC80172022-11-01
00850043061106Dr ZeeResp Devices LLC60012022-11-01
00850043061113Dr ZeeResp Devices LLC60022022-11-01
00850043061120Dr ZeeResp Devices LLC60032022-11-01
00850043061137Dr ZeeResp Devices LLC62402022-11-01
00850043061144Dr ZeeResp Devices LLC62412022-11-01
00860002529011StrongholdHAMMER-PLANE INCADD2019-09-26
00860002529028StrongholdHAMMER-PLANE INCPDD2019-09-26
00888499009410CARDINAL HEALTH ESSENTIALSRGH ENTERPRISESZRTT2402019-05-09
00888499009441CARDINAL HEALTH ESSENTIALSRGH ENTERPRISESZRTT241P2019-05-09
04250105601459n.a.VBM Medizintechnik GmbH35-30-2552020-08-25
07331791012921Freevent Neckband, two-piece, smallAtos Medical AB16522022-11-29
07331791012945Freevent Neckband, two-piece, largeAtos Medical AB16622022-11-29
07331791013621Freevent Neckband, two-piece, smallAtos Medical AB17522022-12-07
07331791013638Freevent Neckband, two-piece, largeAtos Medical AB17622022-12-07
08904428744947OSSEOUS- NeckFit Tube HolderEON MEDITECH PRIVATE LIMITEDEA910532026-03-13
10080196804214MedlineMEDLINE INDUSTRIES, INC.ZPP301P2021-09-14
10812594012188EZCare™ SoftouchNeotech Products LLC"5"" Pink"2021-06-14
10812594012195EZCare™ SoftouchNeotech Products LLC"6"" Pink"2021-06-15