FDA.reportPublic FDA data

Long Tracheal T-Tube

Primary DI
00815347020365
Brand
Long Tracheal T-Tube
Company
HOOD, E BENSON LABORATORIES INC
Model
LT-506-S
Device description
Montgomery Tracheal T-Tube
Published
2015-10-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTOTube, Tracheostomy (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815347020365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815347020365008153470203658153470203650815347020365

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, single-useA sterile hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
076603380
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815347020082Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1512-S2023-11-21
00815347020099Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1814-S2023-11-21
00815347023762Radiopaque Bronchial Stent with PostsRBSP1-1030-S2023-11-21
00815347023779Radiopaque Bronchial Stent with PostsRBSP1-1230-S2023-11-21
00815347023786Radiopaque Bronchial Stent with PostsRBSP1-1240-S2023-11-21
00815347023793Radiopaque Tracheal Stent with PostsRTSP-1450-S2023-11-21
00815347023809Radiopaque Tracheal Stent with PostsRTSP-1650-S2023-11-21
00815347023816Radiopaque Bronchial Stent with PostsRBSP1-1250-S2023-11-21
00815347024011Radiopaque Hour Glass Stent with PostsRHGS-1614-S2023-11-21
00815347024028Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1410-S2023-11-21
00815347024035Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1613-S2023-11-21
00815347020358Extra Long Tracheal T-TubeELT-06-S2015-10-27
00815347020372Long Tracheal T-TubeLT-507-S2015-10-27
00815347020389Extra Long Tracheal T-TubeELT-07-S2015-10-27
00815347020396Extra Long Tracheal T-TubeELT-08-S2015-10-27
00815347020402Long Tracheal T-TubeLT-508-S2015-10-27
00815347020419Extra Long Tracheal T-TubeELT-10-S2015-10-27
00815347020426Long Tracheal T-TubeLT-509-S2015-10-27
00815347020433Long Tracheal T-TubeLT-510-S2015-10-27
00815347020440Extra Long Tracheal T-TubeELT-12-S2015-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783010640Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010657Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010664Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010671Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010695Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010701Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010718Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010725Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010732Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010749Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010756Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010770Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010787Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010794Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010800Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010817Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010824Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010831Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010848Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010855Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010862Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010879Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010886Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010893Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010909Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010916Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010923Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010930Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010947Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010954Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09