FDA.reportPublic FDA data

Tenax Laser Resistant Endotracheal Tube

Primary DI
TG0070
Brand
Tenax Laser Resistant Endotracheal Tube
Company
BRYAN MEDICAL, INC.
Model
TG0070
Device description
Tenax Laser Resistant Endotracheal Tube 7.0mm I.D. x 10.6mm O.D. (32FR)
Published
2020-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200761000Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc.2020-11-25BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
TG0070PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
160067273
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
TG0075Tenax Laser Resistant Endotracheal TubeTG00752020-12-18
KG0530Aeris Balloon Dilation CatheterKG05302020-12-18
KG0630Aeris Balloon Dilation CatheterKG06302020-12-18
KG0730Aeris Balloon Dilation CatheterKG07302020-12-18
KG0830Aeris Balloon Dilation CatheterKG08302020-12-18
KG0930Aeris Balloon Dilation CatheterKG09302020-12-18
KG1030Aeris Balloon Dilation CatheterKG10302020-12-18
KG1240Aeris Balloon Dilation CatheterKG12402020-12-18
KG1640Aeris Balloon Dilation CatheterKG16402020-12-18
KG1840Aeris Balloon Dilation CatheterKG18402020-12-18
TG0055Tenax Laser Resistant Endotracheal TubeTG00552020-12-18
TG0060Tenax Laser Resistant Endotracheal TubeTG00602020-12-18
TG0065Tenax Laser Resistant Endotracheal TubeTG00652020-12-18
TG0050Tenax Laser Resistant Endotracheal TubeTG00502020-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810003750846KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750853ENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750860KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750877KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750884KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750891KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750907KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08