Shiley

Primary DI
20884521205472
Brand
Shiley
Company
Covidien LP
Model
10CN10R
Device description
Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula
Published
2016-09-24
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
K150844000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150844000Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner CannulaCovidien2015-07-14JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521205472PackageGS132In Commercial Distribution
10884521205475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452120547220884521205472
1088452120547510884521205475

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, non-reinforced, non-customized, single-useA 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 not custom-made for a specific patient and is not reinforced with a wire. 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. 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
Length79Millimeter
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
false
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
10884521032903BiosynGMT-2262015-09-01
10884521102163Vascufil88864788-05V2015-08-31
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709204192BivonaICU MEDICAL, INC.JOH2026-09-25
10887709204451BivonaICU MEDICAL, INC.JOH2026-09-25
10887709204734BivonaICU MEDICAL, INC.JOH2026-09-25
10887709204901BivonaICU MEDICAL, INC.JOH2026-09-25
10887709204918BivonaICU MEDICAL, INC.JOH2026-09-25
10887709204925BivonaICU MEDICAL, INC.JOH2026-09-25
10887709204932BivonaICU MEDICAL, INC.JOH2026-09-25
10887709204949BivonaICU MEDICAL, INC.JOH2026-09-25
10887709204826BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204833BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204840BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204857BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204864BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204871BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204888BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204895BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204505BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204512BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204550BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204680BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204697BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204703BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204710BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204727BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204741BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204475BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204482BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204574BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204581BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204598BivonaICU MEDICAL, INC.JOH2026-09-21