FDA.reportPublic FDA data

Merlyn EndoTube

Primary DI
00182151000235
Brand
Merlyn EndoTube
Company
MERLYN ASSOCIATES, INC.
Model
Preformed Oral 420065
Catalog number
420065
Device description
6.5mm ID preformed oral cuffed endotracheal tube with Magill curve, radiopaque line and smooth Murphy tip
Published
2016-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K042683000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042683000WELL LEAD ENDOTRACHEAL TUBEWell Lead Medical Instruments2005-02-18BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10182151000232PackageGS110In Commercial Distribution
00182151000235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1018215100023210182151000232
00182151000235001821510002351821510002350182151000235

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter6.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature32 Degrees Fahrenheit120 Degrees Fahrenheit

Regulatory Flags#

DUNS number
606864184
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00182151000037Merlyn EndoTubeOral/Nasal 4010354010352016-06-01
00182151000044Merlyn EndoTubeOral/Nasal 4010404010402016-06-01
00182151000051Merlyn EndoTubeOral/Nasal 4010454010452016-06-01
00182151000068Merlyn EndoTubeOral/Nasal 4010504010502016-06-01
00182151000075Merlyn EndoTubeOral/Nasal 4010554010552016-06-01
00182151000082Merlyn EndoTube Oral/Nasal 4010604010602016-06-01
00182151000099Merlyn EndoTubeOral/Nasal 4010654010652016-06-01
00182151000105Merlyn EndoTubeOral/Nasal 4010704010702016-06-01
00182151000112Merlyn EndoTubeOral/Nasal 4010754010752016-06-01
00182151000129Merlyn EndoTubeOral/Nasal 4010804010802016-06-01
00182151000136Merlyn EndoTubeOral/Nasal 4010854010852016-06-01
00182151000143Merlyn EndoTubeOral/Nasal 4110304110302016-06-01
00182151000150Merlyn EndoTubeOral/Nasal 4110354110352016-06-01
00182151000167Merlyn EndoTubeOral/Nasal 4110404110402016-06-01
00182151000174Merlyn EndoTubeOral/Nasal 4110454110452016-06-01
00182151000181Merlyn EndoTubePreformed Oral 4200404200402016-06-01
00182151000198Merlyn EndoTubePreformed Oral 4200454200452016-06-01
00182151000204Merlyn EndoTubePreformed Oral 4200504200502016-06-01
00182151000211Merlyn EndoTubePreformed Oral 4200554200552016-06-01
00182151000228Merlyn EndoTubePreformed Oral 4200604200602016-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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