FDA.reportPublic FDA data

Trinity Medical Devices

Primary DI
00813880027575
Brand
Trinity Medical Devices
Company
TRINITY MEDICAL DEVICES INC.
Model
TET230S
Device description
Tracheal Tube UnCuffed 3.0, with Stylet
Published
2024-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813880027575PrimaryGS10
00813880027544Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813880027575008138800275758138800275750813880027575
00813880027544008138800275448138800275440813880027544

GMDN Terms#

Term, Definition table
TermDefinition
Basic endotracheal tube, single-useA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Regulatory Flags#

DUNS number
078728314
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813880027551Trinity Medical DevicesTET150S2024-04-24
00813880027568Trinity Medical DevicesTET170S2024-04-24
00813880027520Trinity Medical DevicesTET150S2024-04-24
00813880027537Trinity Medical DevicesTET170S2024-04-24
00813880027544Trinity Medical DevicesTET230S2024-04-24
00813880027032Trinity Medical DevicesTST600C2023-08-07
00813880027322Trinity Medical DevicesTST600CF008138800273152023-08-07
00813880027513Klear-TracePN022023-08-07
00813880026967Trinity Medical DevicesTST600C2023-08-07
00813880027490Klear-TracePN022023-08-07
00813880022174Klear-Trace20002018-10-15
00813880023102Klear-Trace48002018-10-15
00813880023119Klear-Trace48102018-10-15
00813880025496Trinity Medical DevicesTST6002023-05-31
00813880025502Trinity Medical DevicesTST6002023-05-31
10813880020009Trinity Medical DevicesTAW1402023-02-11
10813880020016Trinity Medical DevicesTAW1502023-02-11
10813880020023Trinity Medical DevicesTAW1602023-02-11
10813880020030Trinity Medical DevicesTAW1702023-02-11
10813880020047Trinity Medical DevicesTAW1802023-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521853812ShileyCovidien LPBTR2026-10-25
10884521853829ShileyCovidien LPBTR2026-10-25
10884521853836ShileyCovidien LPBTR2026-10-25
10884521853843ShileyCovidien LPBTR2026-10-25
10884521853850ShileyCovidien LPBTR2026-10-25
10884521853867ShileyCovidien LPBTR2026-10-25
10884521853874ShileyCovidien LPBTR2026-10-25
14026704934758LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934765LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934772LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934802LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704759191SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759399SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759405SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759412SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759429SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759436SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759443SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759481SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759498SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759504SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759511SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759566SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759573SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759597SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759696SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759740SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759580SHERIDANTELEFLEX INCORPORATEDBTR2026-07-29
00810003750822KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750839KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08