Product Code: BTR


Products Classified as BTR

24Tube, Tracheal (w/wo Connector)Tracheal Tube.

Total Product Life Cycle (TPLC) Devices

24Tube, Tracheal (w/wo Connector)Tracheal Tube.

FDA Consensus Standards

Tube, Tracheal (W/Wo Connector) [38410]21 CFR §868.5730 🔎
Tube, Tracheal (W/Wo Connector) [38412]21 CFR §868.5730 🔎
Tube, Tracheal (W/Wo Connector) [36713]21 CFR §868.5730 🔎
Tube, Tracheal (W/Wo Connector) [36710]21 CFR §868.5730 🔎
Tube, Tracheal (W/Wo Connector) [36711]21 CFR §868.5730 🔎
Tube, Tracheal (W/Wo Connector) [34593]21 CFR §868.5730 🔎
Tube, Tracheal (W/Wo Connector) [38411]21 CFR §868.5730 🔎
Tube, Tracheal (W/Wo Connector) [38530]21 CFR §868.5730 🔎

Pre-market Notifications for BTR

K213028Tenax Laser Resistant Endotracheal TubeBryan Medical , Inc.
K211543Wei Nasal Jet TubeWell Lead Medical Co., LTD.
K200761Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc.
K192324Sheridan Spiral-Flex Endotracheal TubesTeleflexMedical, Inc
K192120Venner PneuXâ„¢ ETT (Endotracheal Tube) 6 Mm, Venner PneuXâ„¢ ETT (Endotracheal Tube) 7 Mm, Venner PneuXâ„¢ ETT (Endotracheal Tube) 8 Mm, Venner PneuXâ„¢ ETT (Endotracheal Tube) 9 MmVenner Medical (Singapore) Pte Ltd
K190878Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube With Salter Flex-Tip And Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube With Salter Flex-Tip And Salter ThinCuffSalter Labs, Inc.
K190630SolidAIRity III Airway Stabilization SystemSecurisyn Medical, LLC
K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd.
K190213Yikang Endotracheal TubeJiangxi Yikang Medical Instrument Group Co., Ltd
K182739Endotracheal Tube With Evacuation LumenWELL LEAD MEDICAL CO., LTD.
K181880VivaSight-SL (TVT) SystemETView Ltd.
K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) With Preloaded StyletNeVap, Inc.
K171917Frova Intubating IntroducerCook Incorporated
K171411IRRIS (Infra-Red-Red Intubation System)A.R Guide In Medical Ltd.
K170234Endotracheal Tube; Reinforced Endotracheal TubeZhanjiang Star Enterprise Co., Ltd

Global Unique Device Identification Database

10351688018243Tube, tracheal (w/wo connector)
00613994556738Tube, tracheal (w/wo connector)
20607411959459Tube, Tracheal (W/Wo Connector)
20607411959442Tube, Tracheal (W/Wo Connector)
20607411959435Tube, Tracheal (W/Wo Connector)
20607411959428Tube, Tracheal (W/Wo Connector)
20607411959411Tube, Tracheal (W/Wo Connector)
20607411959404Tube, Tracheal (W/Wo Connector)
20607411959398Tube, Tracheal (W/Wo Connector)
20607411959329Tube, Tracheal (W/Wo Connector)
20607411959312Tube, Tracheal (W/Wo Connector)
20607411959305Tube, Tracheal (W/Wo Connector)
20607411959299Tube, Tracheal (W/Wo Connector)
20607411959282Tube, Tracheal (W/Wo Connector)
20607411958018Tube, Tracheal (W/Wo Connector)

Maude Adverse Events

CURITYKENDALL GAMMATRON, THAILAND2020-03-31
HUDSON ET TUBE,CF,8.0TELEFLEX MEDICAL2020-03-31
CURITYKENDALL GAMMATRON, THAILAND2020-03-31
CURITYKENDALL GAMMATRON, THAILAND2020-03-31
TAPERGUARDMMJ SA DE CV (USD)2020-03-31
TAPERGUARDMMJ SA DE CV (USD)2020-03-31
SHILEYMMJ SA DE CV (USD)2020-03-30
UNSPECIFIED ENDOTRACH TUBEMMJ SA DE CV(USD)2020-03-30
UNSPECIFIED ENDOTRACH TUBEMMJ SA DE CV(USD)2020-03-30
FROVA INTUBATING INTRODUCERWILLIAM COOK EUROPE2020-03-30
SHILEYMMJ SA DE CV (USD)2020-03-30
SHILEYMMJ SA DE CV (USD)2020-03-30
FROVA INTUBATING INTRODUCERWILLIAM COOK EUROPE2020-03-27
UNSPECIFIED TRACHEAL TUBEMITG - HENEQUEN2020-03-26
CURITYKENDALL GAMMATRON, THAILAND2020-03-26
CURITYKENDALL GAMMATRON, THAILAND2020-03-26
TAPERGUARDMMJ SA DE CV(USD)2020-03-25
SHILEYMMJ SA DE CV (USD)2020-03-24
CURITYKENDALL GAMMATRON, THAILAND2020-03-24
CURITYKENDALL GAMMATRON, THAILAND2020-03-24
CURITYKENDALL GAMMATRON, THAILAND2020-03-24
CURITYKENDALL GAMMATRON, THAILAND2020-03-24
TRACHEAL TUBE (RUSCHELIT)TELEFLEX MEDICAL2020-03-24
HUDSON ET TUBE, CUFFED, SPIRAL-FLEX 7.0TELEFLEX MEDICAL2020-03-23
SHILEYCOVIDIEN LP2020-03-23
SHILEYMMJ SA DE CV (USD)2020-03-20
ETTMALLINCKRODT2020-03-20
CURITYKENDALL GAMMATRON, THAILAND2020-03-20
SHILEYMMJ SA DE CV(USD)2020-03-20
COBRANEUROVISION MEDICAL PRODUCTS, INC.2020-03-20
SHILEYCOVIDIEN AG JUAREZ (MMJ)2020-03-20
SHILEYMMJ SA DE CV(USD)2020-03-20
UNSPECIFIED ENDOTRACH TUBEMMJ SA DE CV (USD)2020-03-20
SHILEYMMJ SA DE CV (USD)2020-03-20
SHILEYMMJ SA DE CV(USD)2020-03-18
SHILEYMMJ SA DE CV (USD)2020-03-18
ENDOTRACHEAL TUBECOVIDIEN2020-03-17
SHILEYCOVIDIEN LLC2020-03-17
MICROCUFF ADULT ENDOTRACHEAL TUBEAVANOS MEDICAL INC.2020-03-16
MICROCUFF ADULT ENDOTRACHEAL TUBEAVANOS MEDICAL INC.2020-03-16
SHILEYMMJ SA DE CV (USD)2020-03-16
SHILEYMMJ SA DE CV (USD)2020-03-16
SHILEYMMJ SA DE CV (USD)2020-03-13
SHILEYMMJ SA DE CV(USD)2020-03-11
UNKNOWN MICROCUFF ENDOTRACHEAL TUBEAVANOS MEDICAL INC.2020-03-11
ENDOTRACHEAL TUBEMEDLINE CANADA2020-03-10
SHILEYMMJ SA DE CV(USD)2020-03-10
PORTEX? SACETT? ENDOTRACHEAL TUBESMITHS MEDICAL ASD; INC.2020-03-10
SHILEYMMJ SA DE CV (USD)2020-03-09
SHILEYMMJ SA DE CV (USD)2020-03-09
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