FDA.reportPublic FDA data

Shiley

Primary DI
10884522042994
Brand
Shiley
Company
Covidien LP
Model
TTH
Device description
Tracheostomy Tube Holder
Published
2016-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
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
20884522042991PackageGS165In Commercial Distribution
30884522042998PackageGS110In Commercial Distribution
10884522042994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452204299120884522042991
3088452204299830884522042998
1088452204299410884522042994

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube neck holder, reusableA noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a reusable device.

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521852273BIS AdvancePMC80CB2026-10-26
10884521783829LigaSureMRASILF192026-10-23
10884521853812Shiley1108602026-10-25
10884521853829Shiley1108652026-10-25
10884521853836Shiley1108702026-10-25
10884521853843Shiley1108752026-10-25
10884521853850Shiley1108802026-10-25
10884521853867Shiley1108852026-10-25
10884521853874Shiley1108902026-10-25
10884521856547Touch SurgeryMDS300282026-10-23
10884521861114Vital SyncVITALSYNCSW032026-10-25
10884521039902Surgipro llVPF-703-MX2015-09-02
10884521063433Ti-CronX-11362015-09-02
10884521073951Versaport PlusNB8STF2016-09-24
10884521195677Surgipro IIVP-653-MX2015-09-02
10884521546349Surgipro IIVP86X2016-09-24
10884521701991MonosofCN793G2017-10-10
10884521702073Surgipro IIVP746XG2017-10-10
10884521702172SurgiproCP41G2017-10-10
10884521705173SurgiproSP690G2017-06-23

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Primary DI, Brand, Company table
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