Shiley

Primary DI
20884521726274
Brand
Shiley
Company
Covidien LP
Model
5CN70ER
Device description
Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula
Published
2020-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K193077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193077000Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien2020-06-01JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521726274PackageGS132In Commercial Distribution
10884521726277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452172627420884521726274
1088452172627710884521726277

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
Angle101degree
Device Size Text, specify0
Device Size Text, specify0
Length68Millimeter
Outer Diameter7Millimeter
Outer Diameter10.1Millimeter

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
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08
10884521845985INVOSPMC71VP-GE2025-07-03
10884521063150ILA3948L2015-08-28
10884521102422Steel88862345-532015-08-31
10884521103863TaperGuard18780S2016-09-24
10884521211933Shiley5-182372017-05-10
10884521543799SigniaSIGPSHELL2017-08-08
10884521713208EdgeE1455B2016-11-18
10884521713277EdgeE1475X2016-11-18
20884521103631Mallinckrodt5-182372015-08-28
20884521105574Mallinckrodt5-185412015-08-28
40884521105578Shiley5-185412018-05-16
10884521543881SigniaSIGMRET2017-07-24
10884521543874SigniaSIGRIG2017-07-31
10884521620254Shiley862342016-09-24
10884521543812SigniaSIGADAPTXL2017-08-08
10884521101098NellcorMAXPACAI2016-09-24
10884521543782SigniaSIGPHANDLE2017-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709194899BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194905BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194912BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194929BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194936BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194943BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194585BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194615BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194790BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194806BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194813BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194820BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194837BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194844BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194851BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194868BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194875BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194882BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194660BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194677BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194684BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194691BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194707BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194714BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194721BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194738BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194745BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194752BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194769BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194776BivonaICU MEDICAL, INC.JOH2026-06-02