Tube Tracheostomy And Tube Cuff
FDA product code JOH · 103 cleared devices
Class 2
Anesthesiology
- Regulation
- 21 CFR 868.5800
- Review panel
- AN
- Implant
- No
- Life sustaining
- Yes
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-09-13 – 2025-12-29
JOH
2025-12-29
JOH
2021-11-26
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
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JOH
2021-08-05
TRACOE vario
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JOH
2020-06-01
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
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JOH
2019-12-12
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
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JOH
2019-03-22
Shiley Neonatal/Pediatric Tracheostomy Tube
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JOH
2018-05-08
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
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JOH
2018-05-07
Weinmann Tracheostomy Exchange Set
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JOH
2018-04-27
TRACOE silcosoft Tracheostomy Tube
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JOH
2017-12-07
Portex Blue Line Ultra Paediatric Tracheosomy Tube
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JOH
2016-02-12
ProTrach Dualcare
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JOH
2013-12-23
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
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JOH
2013-09-06
RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
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JOH
2013-08-12
FAHL TRACHEOSTOMY TUBES (MULTIPLE)
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JOH
2012-10-09
SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
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JOH
2010-06-25
SHIKANI SPEAKING VALVE
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JOH
2010-01-08
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
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JOH
2009-02-23
BIVONA TRACHEOSTOMY TUBES
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JOH
2008-09-12
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
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JOH
2008-05-30
PROVOX MICRON HME
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JOH
2007-10-03
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
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JOH
2005-06-16
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
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JOH
2005-02-18
TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
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JOH
2004-08-02
MARPAC MESSENGER MODEL #501
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JOH
2004-07-29
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
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JOH
2004-07-13
PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
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JOH
2004-02-13
PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
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JOH
2003-11-14
SHILEY FLEXTRA TRACHEOSTOMY TUBE
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JOH
2003-07-18
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
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JOH
2003-03-28
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
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JOH
2003-03-21
PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
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JOH
2002-07-30
TRACH VOX
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JOH
2002-02-21
PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
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JOH
2001-08-15
THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
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JOH
2000-11-08
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
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JOH
2000-04-25
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
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JOH
1999-06-11
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
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JOH
1998-11-13
DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN
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JOH
1998-10-23
SHIKANI-FRENCH SPEAKING VALVE
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JOH
1998-04-14
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
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JOH
1998-02-24
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
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JOH
1998-02-23
IRRIGATION BOTTLE
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JOH
1998-02-13
RUSCH TRACHEOFIX-SET
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JOH
1998-01-20
FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
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JOH
1997-10-10
RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE
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JOH
1997-09-25
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
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JOH
1997-06-26
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
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JOH
1997-02-12
PASSY-MUIR O2 ADAPTER; PMA2000
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JOH
1997-01-17
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
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JOH
1996-10-28
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000
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JOH
1996-10-11
TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER
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JOH
1996-10-04
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
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JOH
1996-09-13
TRACHEOSTOMY TUBES TRACOE-FLEX
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JOH
1996-06-28
RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE
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JOH
1996-05-02
PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
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JOH
1996-03-13
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED
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JOH
1996-01-24
MALLINCKRODT SHILEY 15MM CAP
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JOH
1996-01-19
THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER,
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JOH
1995-12-22
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
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JOH
1995-10-31
SUPERSLICK
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JOH
1995-07-07
PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)
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JOH
1995-01-13
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
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JOH
1994-12-27
EUROMEDICAL POLY TRACHEOTOMY TUBE
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JOH
1994-10-27
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
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JOH
1994-08-30
REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS
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JOH
1994-06-15
TRACHEOSTOMY CARE TRAY
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JOH
1994-03-23
PERCUTANEOUS TRACHEOSTOMY KIT
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JOH
1993-11-03
TRACHEOSTOMY CARE TRAY
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JOH
1993-10-01
SALINE SOLUTION-STERILE
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JOH
1993-08-27
PERCUTANEOUS TRACHEOSTOMY TUBE KIT
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JOH
1993-08-27
TRACHEOSTOMY KIT
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JOH
1993-08-18
TRACHEOSTOMY CARE TRAY
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JOH
1993-07-07
TRACHEOSTOMY CARE KIT (STERILE)
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JOH
1993-07-02
SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF
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JOH
1993-06-16
TRACHEOSTOMY CARE KIT
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JOH
1993-02-17
COMBINATION TRACH TIE & VENTILATOR ANTIDISCONNECT
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JOH
1993-01-07
BIVONA HYPERFLEX TRACHEOSTOMY TUBE
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JOH
1992-12-29
BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
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JOH
1992-12-11
TRACHEOSTOMY TUBE AND TUBE CUFF
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JOH
1992-06-29
NEEDLECRIC
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JOH
1992-01-30
BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION
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JOH
1991-10-23
BIVONA CUFF MAINTENANCE DEVICE (CMD)
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JOH
1991-10-23
BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
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JOH
1991-08-09
BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
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JOH
1991-07-17
BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.
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JOH
1991-05-20
HYGIENA-TRACH
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JOH
1991-04-08
TRACHEOSTOMY CARE KIT
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JOH
1990-10-02
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
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JOH
1990-09-04
PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM
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JOH
1990-04-23
HYDRASORB(TM)
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JOH
1990-03-16
BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE
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JOH
1990-03-12
HOOD SPEAKING VALVE
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JOH
1990-01-22
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
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JOH
1990-01-22
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
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JOH
1989-10-13
BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE
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JOH
1989-10-13
BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE
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JOH
1989-08-01
MODIFIED DECANNULATION STOPPER
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JOH
1989-07-20
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
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JOH
1989-02-27
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
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JOH
1989-02-27
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
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