BTO

Product Code: BTO


Products Classified as BTO

21Tube, Tracheostomy (w/wo Connector)Tracheostomy Tube And Tube Cuff.

Total Product Life Cycle (TPLC) Devices

21Tube, Tracheostomy (w/wo Connector)Tracheostomy Tube And Tube Cuff.

FDA Consensus Standards

Tube, Tracheostomy (W/Wo Connector) [38410]21 CFR §868.5800 🔎
Tube, Tracheostomy (W/Wo Connector) [38412]21 CFR §868.5800 🔎

Pre-market Notifications for BTO

K192511Venner PneuXâ„¢ TT (Tracheostomy Tube) Size 7.0 Mm, Venner PneuXâ„¢ TT (Tracheostomy Tube) Size 8.0 Mm, Venner PneuXâ„¢ TT (Tracheostomy Tube) Size 9.0 MmVenner Medical (Singapore) PTE Ltd
K173384BLUselect, Non-fenestrated, BLUselect, Non-fenestrated, Cont, BLUselect, Fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, Without TubeSmiths Medical ADS, Inc.
K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)PRIMED HALBERSTADT MEDIZINTECHNIK GMBH
K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULAREGULATORY AND MARKETING SERVICES, INC.
K100950VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBEVENNER MEDICAL (SINGAPORE) PTE LTD
K100480ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACHVITALTEC CORPORATION
K100283VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTICCOOK, INC.
K083031PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KITSMITHS MEDICAL ASD, INC.
K073702PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTORLAZARUS MEDICAL LLC
K062104TALKING TRACHENGINEERED MEDICAL SYSTEMS, INC.
K060945PORTEX PERCUTANEOUS TRACHEOSTOMY KITSMITHS MEDICAL INTERNATIONAL
K051587TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470TRACOE MEDICAL GMBH
K050379CS MEDICAL ADULT TTCF CATHETERCS MEDICAL INC.
K042684WELL LEAD TRACHEOSTOMY TUBEWELL LEAD MEDICAL INSTRUMENTS
K030570BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBEPORTEX LTD.

Global Unique Device Identification Database

30351688047919Tube, tracheostomy (w/wo connector)
30351688047902Tube, tracheostomy (w/wo connector)
10351688038715Tube, tracheostomy (w/wo connector)
30351688026389Tube, tracheostomy (w/wo connector)
00757770529278Tube, Tracheostomy (W/Wo Connector)
00757770529261Tube, Tracheostomy (W/Wo Connector)
20815123011512Tube, Tracheostomy (W/Wo Connector)
20815123011505Tube, Tracheostomy (W/Wo Connector)
20815123011499Tube, Tracheostomy (W/Wo Connector)
20815123011482Tube, Tracheostomy (W/Wo Connector)
20815123011475Tube, Tracheostomy (W/Wo Connector)
20815123011468Tube, Tracheostomy (W/Wo Connector)
20815123011451Tube, Tracheostomy (W/Wo Connector)
20815123011444Tube, Tracheostomy (W/Wo Connector)
20815123011437Tube, Tracheostomy (W/Wo Connector)

Maude Adverse Events

CUSTOMIZED PORTEX BIVONA TRACHEOSTOMY TUBESMITHS MEDICAL ASD, INC.2020-03-21
CUSTOMIZED PORTEX BIVONA TRACHEOSTOMY TUBESMITHS MEDICAL ASD, INC.2020-03-21
SHILEYMALLINCKRODT DAR SRL2020-03-20
PORTEX UNIPERC INNER CANNULAESMITHS MEDICAL ASD, INC.2020-03-16
PORTEX? UNIPERC? ADJUSTABLE FLANGE TRACHEOSTOMY TUBESMITHS MEDICAL ASD; INC.2020-03-11
PORTEX? UNIPERC? ADJUSTABLE FLANGE TRACHEOSTOMY TUBESMITHS MEDICAL ASD; INC.2020-02-26
RUSCH LARYNGOFLEX WITH VALVETELEFLEX MEDICAL2020-02-21
SHILEYMMJ SA DE CV (USD)2020-02-13
SHILEYCOVIDIEN AG JUAREZ (MMJ)2020-02-10
SHILEYCOVIDIEN AG JUAREZ (MMJ)2020-02-10
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBESMITHS MEDICAL ASD, INC.2020-02-09
BIVONA UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBESMITHS MEDICAL ASD, INC.2020-02-09
SHILEYMITG - HENEQUEN2020-01-20
PORTEX? UNIPERC? ADJUSTABLE TRACHEOSTOMY TUBESMITHS MEDICAL ASD; INC.2020-01-15
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
INNER CANNULAMEDPLAST / VIANT MEDICAL, INC.2020-01-06
SHILEY 8PERCCOVIDIEN2019-12-31
SMITHS MEDICAL UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMYSMITHS MEDICAL ASD, INC.2019-11-18
SHILEYMMJ SA DE CV (USD)2019-10-25
PORTEX? ENDOTRACHEAL TUBESMITHS MEDICAL ASD; INC.2019-10-23
PORTEX? ENDOTRACHEAL TUBESMITHS MEDICAL ASD; INC.2019-10-23
SHILEYMMJ SA DE CV (USD)2019-09-26
TUBE, TRACHEOSTOMY (W/WO CONNECTOR), PRODUCT CODE: BTOSMITHS MEDICAL ASD, INC.2019-09-09
SHILEYMMJ SA DE CV(USD)2019-08-26
BIVONASMITHS MEDICAL ASD, INC2019-08-22
BIVONASMITHS MEDICAL ASD, INC2019-08-22
BIVONASMITHS MEDICAL ASD, INC2019-08-22
BIVONASMITHS MEDICAL ASD, INC2019-08-22
PORTEX? UNIPERC? ADJUSTABLE FLANGE TRACHEOSTOMY TUBESSMITHS MEDICAL ASD; INC.2019-08-14
COVIDIEN SHILEY #6 CFNCOVIDIEN SHILEY2019-08-07
COVIDIEN SHILEY #6 CFNCOVIDIEN SHILEY2019-08-07
COVIDIEN SHILEY #6 CFNCOVIDIEN2019-08-07
PORTEX BIVONA FOME-CUF ADULT TRACHEOSTOMY TUBE WITH TALK ATTACHMENTSMITHS MEDICAL ASD, INC.2019-08-02
PORTEX AIRWAY NASOPHARYNGEALSMITHS MEDICAL ASD,INC2019-07-31
BLUE LINE ULTRA TRACHEOSTOMY TUBESMITHS MEDICAL ASD, INC.2019-07-24
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.