Shiley

Primary DI
10884522029032
Brand
Shiley
Company
Covidien LP
Model
5.0PLC
Catalog number
5.0PLC
Device description
Pediatric Tracheostomy Tube Long Cuffed
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
K955680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955680000SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFEDMallinckrodt Medical1996-03-13JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884522029032PackageGS1108In Commercial Distribution
20884522029039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452202903210884522029032
2088452202903920884522029039

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
Device Size Text, specify0

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
10884521038967ValleylabE250510FRNSB2025-03-27
10884524002880ValleylabE250510FRNSB2025-03-27
10884521039100ValleylabE3310NSB2016-09-24
10884521141117WarmTouch50308902019-02-06
10884521205024Shiley4CN65R2016-09-24
10884521205420Shiley5CN70R2016-09-24
10884521205437Shiley6CN75R2016-09-24
10884521205444Shiley7CN80R2016-09-24
10884521205451Shiley8CN85R2016-09-24
10884521205468Shiley9CN90R2016-09-24
10884521205475Shiley10CN10R2016-09-24
10884521205482Shiley4UN65R2016-09-24
10884521205499Shiley5UN70R2016-09-24
10884521205505Shiley6UN75R2016-09-24
10884521205512Shiley7UN80R2016-09-24
10884521205529Shiley8UN85R2016-09-24
10884521205536Shiley9UN90R2016-09-24
10884521205543Shiley10UN10R2016-09-24
10884521815360NellcorMAXFAST2021-08-09
10884521815469NellcorMAXFASTI2021-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709198033BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198040BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198057BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198071BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198088BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198125BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198132BivonaICU MEDICAL, INC.JOH2026-07-13
10887709197814BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197821BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197913BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197920BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197944BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197951BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197968BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197975BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197982BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197999BivonaICU MEDICAL, INC.JOH2026-07-10
10887709198002BivonaICU MEDICAL, INC.JOH2026-07-10
10887709198019BivonaICU MEDICAL, INC.JOH2026-07-10
10887709198026BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197265BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197289BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197838BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197845BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197852BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197869BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197876BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197883BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197890BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197906BivonaICU MEDICAL, INC.JOH2026-07-09