FDA.reportPublic FDA data

KENTRON

Primary DI
00810003750402
Brand
KENTRON
Company
KENTRON HEALTHCARE, INC.
Model
739925
Device description
ENDOTRACHEAL TUBE UNCUFFED 2.5MM WITH MURPHY EYE, RADIO OPAQUE MARKER AND 15MM TUBE CONNECTOR
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K140228000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140228000DISPOSABLE TRACHEAL TUBESuzhou Weikang Medical Apparatus Co., Ltd.2014-12-18BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810003750409PackageGS110In Commercial Distribution
20810003750406PackageGS110In Commercial Distribution
00810003750402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000375040910810003750409
2081000375040620810003750406
00810003750402008100037504028100037504020810003750402

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.

Contacts#

Phone, Email table
PhoneEmail
615-384-0573KENTRON@KENTRONMEDICAL.COM

Regulatory Flags#

DUNS number
618825723
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810003750396KENTRON7399202026-05-27
00810003750419KENTRON7399302026-05-27
00810003750426KENTRON7399352026-05-27
00810003750433KENTRON7399402026-05-27
00810003750440KENTRON7399452026-05-27
00810003750457KENTRON7399502026-05-27
00810003750464KENTRON7399552026-05-27
00810003750471KENTRON7399602026-05-27
00810003750488KENTRON7399652026-05-27
00810003755896KENOREX3811002026-05-18
00810003755902KENOREX3811102026-05-18
00810003755919KENOREX3811202026-05-18
00810003755926KENOREX3811302026-05-18
00810003755933KENOREX3811402026-05-18
00810003755940KENOREX3811502026-05-18
00810003755957KENOREX8877102026-05-18
00810003752000KENOREX3935062026-05-17
00810003752017KENOREX3935082026-05-17
00810003752024KENOREX3935102026-05-17
00810003752031KENOREX3935122026-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003750396KENTRONKENTRON 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
00810003750488KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
10197344104659MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104666MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104673MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104680MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104697MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104703MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104710MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104727MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104734MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104741MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104758MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104765MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104772MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104789MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104796MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104802MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104819MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104826MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104833MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104840MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104857MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12