Shiley

Primary DI
40884522005341
Brand
Shiley
Company
Covidien LP
Model
8SIC
Device description
Spare Inner Cannula
Published
2015-08-31
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
K930895000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930895000SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIFMallinckrodt Medical Tpi, Inc.1993-07-02JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884522005340PackageGS110In Commercial Distribution
60884522005345PackageGS124In Commercial Distribution
40884522005341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452200534010884522005340
6088452200534560884522005345
4088452200534140884522005341

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
Device Size Text, specify0

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

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10884521039100ValleylabE3310NSB2016-09-24
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10884521205420Shiley5CN70R2016-09-24
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10884521205444Shiley7CN80R2016-09-24
10884521205451Shiley8CN85R2016-09-24
10884521205468Shiley9CN90R2016-09-24
10884521205475Shiley10CN10R2016-09-24

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