FDA.reportPublic FDA data

Tracheostomy tube, reinforced, non-customized, reusable

Definition
An armoured, hollow cylinder that is inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway, typically for a patient with unusual neck mass, however it is not custom-made for a specific patient. It is constructed of plastic with wire reinforcement to provide additional resistance to kinking and may include an inner cannula. It is available in cuffed, uncuffed versions, and in a variety of sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-patient, reusable device after appropriate cleaning.
GUDID devices
16,550
Last updated
2026-06-06 06:06:42

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10887709194431BivonaICU MEDICAL, INC.FU26EN35NGE188N2026-05-28
10887709194448BivonaICU MEDICAL, INC.FU26EN35NGE189N2026-05-28
10887709194455BivonaICU MEDICAL, INC.XT26ES70NSC190N2026-05-28
10887709194486BivonaICU MEDICAL, INC.FT26EN35NGF193N2026-05-28
10887709194509BivonaICU MEDICAL, INC.FT26EN40NGF194N2026-05-28
10887709194226BivonaICU MEDICAL, INC.FT26EN35NSF182N2026-05-27
10887709194233BivonaICU MEDICAL, INC.FU26EN40NGA184N2026-05-27
10887709194240BivonaICU MEDICAL, INC.FT26EN60NSA185N2026-05-27
10887709194356BivonaICU MEDICAL, INC.FT26EN40NSF186N2026-05-27
10887709142753BivonaICU MEDICAL, INC.ZT24LN80ZSZ126N2025-01-16
10887709144726BivonaICU MEDICAL, INC.HT25AS90NSC146N2025-01-16
10887709144733BivonaICU MEDICAL, INC.HT25AS90NSC145N2025-01-16
10887709144764BivonaICU MEDICAL, INC.FT25AN40NGF158N2025-01-16
10887709144771BivonaICU MEDICAL, INC.ZZ25AN75NTC150N2025-01-16
10887709144801BivonaICU MEDICAL, INC.ZZ25AN75NTC153N2025-01-16
10887709144832BivonaICU MEDICAL, INC.FT25AN35NGE159N2025-01-16
10887709144849BivonaICU MEDICAL, INC.XU25AS40NGF160N2025-01-16
10887709144856BivonaICU MEDICAL, INC.HA25AS80NSC161N2025-01-16
10887709144863BivonaICU MEDICAL, INC.FT24JN35NSE007S2025-01-16
10887709144870BivonaICU MEDICAL, INC.FT25AN40NSE162N2025-01-17
10887709144887BivonaICU MEDICAL, INC.FU25AN50NSA164N2025-01-17
10887709144894BivonaICU MEDICAL, INC.FT25AN35NGE165N2025-01-17
10887709144900BivonaICU MEDICAL, INC.FT25AN60NGA163N2025-01-17
10887709144917BivonaICU MEDICAL, INC.HU25AS60NSC166N2025-01-17
10887709144924BivonaICU MEDICAL, INC.FT25AN50NGF167N2025-01-17
10887709144931BivonaICU MEDICAL, INC.FT25AN30NGF168N2025-01-17
10887709146133BivonaICU MEDICAL, INC.FU25AN45NSF268N2025-01-29
10887709146140BivonaICU MEDICAL, INC.FU25AN40NSF269N2025-01-29
10887709146164BivonaICU MEDICAL, INC.FT25AN40NGE267N2025-01-29
10887709146201BivonaICU MEDICAL, INC.FT25AN40NSE274N2025-01-29
10887709146218BivonaICU MEDICAL, INC.FT25AN35NSE275N2025-01-29
10887709157733BivonaICU MEDICAL, INC.FT25EN40NGF086N2025-05-27
10887709157740BivonaICU MEDICAL, INC.FT25EN35NSE085N2025-05-27
10887709157757BivonaICU MEDICAL, INC.FT25EN45NSF087N2025-05-27
10887709157764BivonaICU MEDICAL, INC.XT25ES55NGC088N2025-05-27
10887709157771BivonaICU MEDICAL, INC.XT25ES50NGC089N2025-05-27
10887709158877BivonaICU MEDICAL, INC.FT25EN35NSF188N2025-05-27
10887709158884BivonaICU MEDICAL, INC.FT25EN30NSF189N2025-05-27
10887709158891BivonaICU MEDICAL, INC.FU25EN40NGA193N2025-05-27
10887709158907BivonaICU MEDICAL, INC.XU25ES45NGF191N2025-05-22
10887709158914BivonaICU MEDICAL, INC.XU25ES40NGE192N2025-05-22
10887709158921BivonaICU MEDICAL, INC.FT25EN40NSA194N2025-05-22
10887709158938BivonaICU MEDICAL, INC.HU25ES70NSC200N2025-05-22
10887709158952BivonaICU MEDICAL, INC.FT25EN55NSF198N2025-05-22
10887709158976BivonaICU MEDICAL, INC.FT25EN40NSF201N2025-05-22
10887709158983BivonaICU MEDICAL, INC.FT25EN55NGF199N2025-05-22
10887709159041BivonaICU MEDICAL, INC.FU25EN55NGA207N2025-05-27
10887709159058BivonaICU MEDICAL, INC.XT25ES70NSC205N2025-05-27
10887709159065BivonaICU MEDICAL, INC.ST23HN40NSA243S2025-05-27
10887709159133BivonaICU MEDICAL, INC.ST25EN75NSC215N2025-05-27
10887709159140BivonaICU MEDICAL, INC.FT25EN45NGA220N2025-05-27
10887709159157BivonaICU MEDICAL, INC.XP25ES35NGF219N2025-05-27
10887709159164BivonaICU MEDICAL, INC.ST25EN60NSC209N2025-05-27
10887709159171BivonaICU MEDICAL, INC.FT25EN65NSC213S2025-05-27
10887709159188BivonaICU MEDICAL, INC.FU25EN60NGF214N2025-05-27
10887709159201BivonaICU MEDICAL, INC.FU25EN60NSA217S2025-05-27
10887709159218BivonaICU MEDICAL, INC.FT25EN45NSF221N2025-05-27
10887709161990BivonaICU MEDICAL, INC.FT25FN35NGF214N2025-06-24
10887709162003BivonaICU MEDICAL, INC.FU25FN50NSF217N2025-06-24
10887709162010BivonaICU MEDICAL, INC.FT25FN40NSE218N2025-06-24
10887709162027BivonaICU MEDICAL, INC.FU25FN55NSF216N2025-06-24
10887709162539BivonaICU MEDICAL, INC.ST25FN55NSC271N2025-07-06
10887709162553BivonaICU MEDICAL, INC.FU25FN35NGE267N2025-07-06
10887709162560BivonaICU MEDICAL, INC.FU25FN45NGF261N2025-07-06
10887709162591BivonaICU MEDICAL, INC.FT25FN55NGC265N2025-07-06
10887709162607BivonaICU MEDICAL, INC.FT25FN55NGF258S2025-07-06
10887709162614BivonaICU MEDICAL, INC.HU25FS70NSC254N2025-07-06
10887709162621BivonaICU MEDICAL, INC.FU25FN50NGA253N2025-07-06
10887709162720BivonaICU MEDICAL, INC.FU25GN25NGE004N2025-07-06
10887709162737BivonaICU MEDICAL, INC.FU25GN30NGE003N2025-07-06
10887709162751BivonaICU MEDICAL, INC.XA25FS80NSC255S2025-07-06
10887709162768BivonaICU MEDICAL, INC.FU25GN45NGF007N2025-07-06
10887709162775BivonaICU MEDICAL, INC.FU25GN40NSE008N2025-07-06
10887709162812BivonaICU MEDICAL, INC.FT25GN40NGE012N2025-07-06
10887709162829BivonaICU MEDICAL, INC.FT25GN40NGF011N2025-07-06
10887709162836BivonaICU MEDICAL, INC.FU25GN45NSF013N2025-07-06
10887709162843BivonaICU MEDICAL, INC.FU25GN35NGE014N2025-07-06
10887709162850BivonaICU MEDICAL, INC.FU25GN35NGE015N2025-07-06
10887709162867BivonaICU MEDICAL, INC.FU25GN35NGE016N2025-07-06
10887709162874BivonaICU MEDICAL, INC.FU25GN45NGF017N2025-07-06