Shiley

Primary DI
30884521857524
Brand
Shiley
Company
Covidien LP
Model
CAP
Device description
15 mm Cap
Published
2026-02-27
Public version status
New
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
K954749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954749000MALLINCKRODT SHILEY 15MM CAPMallinckrodt Medical1996-01-24JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521857527PackageGS110In Commercial Distribution
30884521857524PackageGS124In Commercial Distribution
10884521857520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452185752720884521857527
3088452185752430884521857524
1088452185752010884521857520

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

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

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10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
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10884521198807superDimensionSDM32016-09-24
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