FDA.reportPublic FDA data

EndoFlex

Primary DI
00182151000587
Brand
EndoFlex
Company
MERLYN ASSOCIATES, INC.
Model
Oral/Nasal 122080
Catalog number
122080
Device description
8.0mm ID oral/nasal endotracheal tube with inflatable tapered cuff, 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
K031794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031794000ENDOFLEX TRACHEAL TUBEMerlyn Associates, Inc.2004-03-12BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10182151000584PackageGS110In Commercial Distribution
00182151000587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1018215100058410182151000584
00182151000587001821510005871821510005870182151000587

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 Diameter8Millimeter

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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