Tube, Tracheostomy (W/Wo Connector)
FDA product code BTO · 129 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
- 1976-12-16 – 2026-09-11
BTO
2026-09-11
BTO
2025-06-10
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm
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BTO
2024-03-22
Pilling Tracheostomy Tubes
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BTO
2020-07-22
Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
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BTO
2018-04-10
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
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BTO
2012-05-24
PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
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BTO
2011-03-24
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
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BTO
2010-07-13
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
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BTO
2010-06-11
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
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BTO
2010-04-23
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
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BTO
2009-08-18
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
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BTO
2008-06-26
PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR
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BTO
2007-04-20
TALKING TRACH
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BTO
2006-06-19
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
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BTO
2005-10-25
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
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BTO
2005-07-12
CS MEDICAL ADULT TTCF CATHETER
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BTO
2005-02-17
WELL LEAD TRACHEOSTOMY TUBE
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BTO
2003-11-18
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
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BTO
2003-09-17
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
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BTO
2003-08-27
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
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BTO
2002-07-23
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
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BTO
1999-10-27
CRICOTHYROTOMY TUBE
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BTO
1998-06-17
SCOOP 1
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BTO
1997-03-19
TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
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BTO
1996-08-27
CPR TRACHEOTOMY CARE TRAY
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BTO
1996-08-15
MOORE TRACHEOSTOMY TUBE
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BTO
1996-05-16
LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
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BTO
1995-08-09
TRACHEOSTOMY CARE KIT
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BTO
1995-02-27
SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
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BTO
1995-02-27
SSV PHONATE(TM) SHILEY SPEAKING VALVE
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BTO
1995-02-14
TRACHEOSTOMY CARE KIT
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BTO
1993-06-16
TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)
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BTO
1993-04-02
TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
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BTO
1993-01-06
TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
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BTO
1993-01-06
TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
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BTO
1992-12-10
TRACHEOSTOMY CARE SET WITH GLOVES
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BTO
1992-12-03
CMI STOMA COVERS
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BTO
1992-09-02
LOW PROFILE TRACHEOSTOMY TUBE
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BTO
1992-08-27
TRACHEOSTOMY CARE KIT
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BTO
1992-08-27
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
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BTO
1992-07-27
BIVONA TRACHEAL T-TUBE STENT
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BTO
1992-07-10
EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF
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BTO
1991-08-16
TRACHEOSTOMY TUBE AND CUFF
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BTO
1991-06-19
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
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BTO
1990-09-25
D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
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BTO
1990-08-17
PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
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BTO
1990-08-10
MODIFIED SCOOP TRANSTRACHEAL CATHETERS
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BTO
1990-05-18
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
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BTO
1990-05-18
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
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BTO
1990-04-23
SHILEY PHONATION VALVE
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BTO
1990-03-16
STAT-TRACH(TM) VENTILATION CATHETER
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BTO
1990-02-22
TRACHEOSTOMY TRAY
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BTO
1990-01-09
TRAUMAFUSE TRACH SHIELD
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BTO
1989-11-07
HEIMLICH MICRO TRACH
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BTO
1989-08-07
HOOD PEDIATRIC TRACHEOSTOMY TUBE
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BTO
1989-05-25
MODIFIED ADULT CRICOTHYROIDOTOMY KIT
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BTO
1989-04-27
AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)
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BTO
1989-01-17
SHILEY PERC TRACHEOSTOMY SYSTEM
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BTO
1988-11-03
PREMIER DECANNULATION STOPPER
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BTO
1988-11-02
FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.
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BTO
1988-06-28
HOOD TRACHEAL STOMA BUTTON
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BTO
1988-03-09
SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
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BTO
1988-02-29
PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP
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BTO
1988-02-29
PREFILLED WATER FOR IRRIGATION USP
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BTO
1988-02-29
SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT
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BTO
1988-02-12
MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
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BTO
1987-12-31
QUICKTRACH
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BTO
1987-11-24
TODD MEDICAL/SKILLED CARE PRODUCTS
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BTO
1987-09-16
LARKEL DEVICE W/ATTACHMENTS A-H
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BTO
1987-06-08
MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.
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BTO
1987-05-14
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
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BTO
1987-01-15
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
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BTO
1986-11-03
TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)
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BTO
1986-09-09
RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM
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BTO
1986-08-06
MINI-TRACH KIT
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BTO
1986-06-18
FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
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BTO
1986-05-09
MICRO-TRACHEOSTOMY CARE KIT
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BTO
1986-04-11
TRACHEAL TUBES
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BTO
1986-03-04
TRACHEOSTOMY CARE KIT
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BTO
1986-02-03
TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER
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BTO
1986-01-27
LARYNGECTOMY TUBE, CUFFED
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BTO
1985-12-19
THE HOOD LIFE SAVER
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BTO
1985-12-06
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
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BTO
1985-09-05
LGT TUBE
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BTO
1985-07-08
BIVONA TRACHEOSTOMA VALVE II
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BTO
1985-06-07
PASSY-MUIR TRACH VALVE
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BTO
1985-05-28
BFW VOICE GENERATOR
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BTO
1985-03-11
TRACHEOSTOMY CARE KIT
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BTO
1985-03-11
TRACHEOSTOMY CARE KIT
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BTO
1985-03-11
TRACHEOSTOMY CARE TRAY
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BTO
1984-10-23
WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR
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BTO
1984-10-19
SHILEY DISPOS. DECANNULATION PLUG W/SW/
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BTO
1984-10-19
SHILEY DISPOS. CANNULA FENESTRATED LOW
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BTO
1984-10-15
PERCUTANEOUS CRICOTHYROIDOTOMY
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BTO
1984-09-19
TRACHEAL TUBE 16 GAUGE-1.65MM-
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BTO
1984-07-06
ALL-HANDS TRACHEOSTOMY CARE SET 0101
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BTO
1984-06-14
MONTGOMERY TRACHEAL T-TUBE
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BTO
1984-05-02
PEDIA-TRAKE CRICOTHYROTOMY KIT
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BTO
1984-04-30
COMMUNI-TRACH TUBE
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BTO
1984-03-15
3-DAY BIOINDICATOR RELEASE FOR RESPIR
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