FDA.reportPublic FDA data

Technical Products

Primary DI
B051TP09T1
Brand
Technical Products
Company
TECHNICAL PRODUCTS INC
Model
TP-09T
Device description
T-tube
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013321000SILICONE TRACHEAL T-TUBESTechnical Products, Inc.2002-06-04BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B051TP09T1PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter9Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
040679649
Device count
1
Lot or batch
true
Manufacturing 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
B051EZ0813Technical ProductsEZ-0813EZ-08132024-02-16
B051EZ0815Technical ProductsEZ-0815EZ-08152024-02-16
B051EZ0817Technical ProductsEZ-0817EZ-08172024-02-16
B051EZ0819Technical ProductsEZ-0819EZ-08192024-02-16
B051EZ0821Technical ProductsEZ-0821EZ-08212024-02-16
B051EZ0823Technical ProductsEZ-0823EZ-08232024-02-16
B051EZ1111Technical ProductsEZ-1111EZ-11112024-02-16
B051EZ1113Technical ProductsEZ-1113EZ-11132024-02-16
B051EZ1115Technical ProductsEZ-1115EZ-11152024-02-16
B051EZ1119Technical ProductsEZ-1119EZ-11192024-02-16
B051EZ1122Technical ProductsEZ-1122EZ-11222024-02-16
B051EZ1124Technical ProductsEZ-1124EZ-11242024-02-16
B051EZ1127Technical ProductsEZ-1127EZ-11272024-02-16
B051EZ1130Technical ProductsEZ-1130EZ-11302024-02-16
B051EZ1135Technical ProductsEZ-1135EZ-11352024-02-16
B051EZ1138Technical ProductsEZ-1138EZ-11382024-02-16
B051EZ1311Technical ProductsEZ-1311EZ-13112024-02-16
B051EZ1313Technical ProductsEZ-1313EZ-13132024-02-16
B051EZ1315Technical ProductsEZ-1315EZ-13152024-02-16
B051EZ1319Technical ProductsEZ-1319EZ-13192024-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003750495KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750501KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750518KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750525KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750532KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750549KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750556KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750563KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750570KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750587KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750594KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750600KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750617KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750624KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750631KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750648KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750655KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750662KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750679KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750686KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750693KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750396KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750402KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750419KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750426KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750433KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750440KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750457KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750464KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750471KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27