FDA.reportPublic FDA data

Shiley

Primary DI
10884521177178
Brand
Shiley
Company
Covidien LP
Model
4.5NEF-P
Device description
Neonatal Tracheostomy Tube Cuffless Disposable, Bedside Tray
Published
2021-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
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
K182861000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182861000Shiley Neonatal/Pediatric Tracheostomy TubeCovidien2019-03-22JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521177175PackageGS124Not in Commercial Distribution
10884521177178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452117717520884521177175
1088452117717810884521177178

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
Angle120degree
Device Size Text, specify0
Length36Millimeter
Outer Diameter4.5Millimeter
Outer Diameter6.7Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521072602V-LocVLOCN204L2015-09-02
20884521126852Sofsilk1700022016-09-24
10884521091986NellcorSC-A-I2026-05-25
10884521758803Vascufil8886470311V-22020-07-19
10884521816312McGRATH MAC350-005-0002021-10-21
10884521816329McGRATH MAC350-013-0002021-08-30
10884521816336McGRATH MAC350-017-0002021-10-18
10884521816343McGRATH MAC350-072-0002022-06-13
10884521824317McGRATH MAC350-005-0002022-09-25
10884521824324McGRATH MAC350-013-0002021-10-30
10884521824331McGRATH MAC350-017-0002021-08-26
10884521824348McGRATH MAC350-072-0002023-06-19
10884521850118McGRATH MAC350-005-0002025-04-27
10884521850125McGRATH MAC350-013-0002025-04-27
10884521850132McGRATH MAC350-017-0002025-04-27
10884521850149McGRATH MAC350-072-0002025-04-27
15060272980310McGRATH MAC350-005-0002021-08-02
15060272980327McGRATH MAC350-013-0002022-01-17
15060272980334McGRATH MAC350-072-0002021-04-18
15060272980341McGRATH MAC350-017-0002021-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709194431BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194448BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194455BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194462BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194486BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194509BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194226BivonaICU MEDICAL, INC.JOH2026-05-27
10887709194233BivonaICU MEDICAL, INC.JOH2026-05-27
10887709194240BivonaICU MEDICAL, INC.JOH2026-05-27
10887709194356BivonaICU MEDICAL, INC.JOH2026-05-27
10884521177192ShileyCovidien LPJOH2021-10-05
10884521177208ShileyCovidien LPJOH2021-10-05
10884521177215ShileyCovidien LPJOH2021-10-05
10884521177222ShileyCovidien LPJOH2021-10-05
10884521177239ShileyCovidien LPJOH2021-10-05
10884521177161ShileyCovidien LPJOH2021-09-11
10884521177154ShileyCovidien LPJOH2021-08-27
10884521177185ShileyCovidien LPJOH2021-08-24
10884521103535ShileyCovidien LPJOH2021-01-18
10884521103542ShileyCovidien LPJOH2021-01-18
10884521103559ShileyCovidien LPJOH2021-01-18
10884521103566ShileyCovidien LPJOH2021-01-18
10884521103573ShileyCovidien LPJOH2019-05-16
10884521103580ShileyCovidien LPJOH2019-05-16
10884521103597ShileyCovidien LPJOH2019-05-16
10884521103603ShileyCovidien LPJOH2019-05-16
10884521103450ShileyCovidien LPJOH2019-05-12
10884521103467ShileyCovidien LPJOH2019-05-12
10884521103474ShileyCovidien LPJOH2019-05-12
10884521103481ShileyCovidien LPJOH2019-05-12