Shiley

Primary DI
10884522031981
Brand
Shiley
Company
Covidien LP
Model
8LPC-S
Catalog number
8LPC-S
Device description
Evac Tracheostomy Tube with Inner Cannula
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
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
10884522031981PackageGS1108In Commercial Distribution
20884522031988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452203198110884522031981
2088452203198820884522031988

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
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
10884521171534Nellcor10005941-SG2022-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709207230BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207247BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207254BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207261BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207278BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207339BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207346BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207353BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207360BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207377BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207100BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207117BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207124BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207131BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207148BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207155BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207162BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207179BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207193BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207209BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207216BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207223BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207032BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207049BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207056BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207063BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207070BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207087BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207094BivonaICU MEDICAL, INC.JOH2026-10-21
10887709206905BivonaICU MEDICAL, INC.JOH2026-10-20