FDA.reportPublic FDA data

Shiley

Primary DI
10884521176294
Brand
Shiley
Company
Covidien LP
Model
10UN10H
Catalog number
10UN10H
Device description
Adult Flexible Tracheostomy Tube with TaperGuar Cuff Disposable Inner Cannula
Published
2017-05-25
Public version status
Update
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
JOHTube tracheostomy and tube cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142296000Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner CannulaCovidien2015-02-24JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521176294PackageGS132In Commercial Distribution
20884521176291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452117629410884521176294
2088452117629120884521176291

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
Angle90degree
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter13.8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09
10884521837126ILLUMISITEILS-1000-CS2024-08-09
10884521837133ILLUMISITEILS-1000-CS2024-08-09
10884521837140ILLUMISITEILS-1000-CS2024-08-09
10884521837157ILLUMISITEILS-1000-CS2024-08-09
10884521842915ILLUMISITEILS-1000-CS2024-08-09
10884521837096ILLUMISITEILS-1000-CS2023-09-17
10884521199996superDimensionAAS00161-20RAAS00161-20R2016-09-24
10884521747425superDimensionPMB00667-012018-02-28
10884521747432superDimensionPMB00569-012018-02-28
10884521199989superDimensionAAS00161-202016-09-24
10884521747418superDimensionILS-0001-FN2018-02-28

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Primary DI, Brand, Company table
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