Shiley

Primary DI
50884522007090
Brand
Shiley
Company
Covidien LP
Model
6LGT
Device description
Laryngectomy Tube
Published
2015-08-28
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

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
K962173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962173000SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIESMallinckrodt Medical1996-10-04JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60884522007097PackageGS1108In Commercial Distribution
50884522007090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088452200709760884522007097
5088452200709050884522007090

GMDN Terms#

Term, Definition table
TermDefinition
Laryngectomy tubeA hollow device intended to maintain tracheostoma patency immediately after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis (narrowing) in the months following the procedure. It is a soft plastic or silicone curved/contoured tube, similar to a tracheostomy tube, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length50Millimeter

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

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