FDA.reportPublic FDA data

Shiley

Primary DI
10884522008792
Brand
Shiley
Company
Covidien LP
Model
125239
Device description
Endobronchial Tube Left with Carinal Hook;Endobronchial Suction Catheter;Endobronchial Tube Accessories
Published
2018-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTSTUBE, BRONCHIAL (W/WO CONNECTOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTSTube, Bronchial (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K771219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K771219000BRONCHO-CATHMallinckrodt Critical Care1977-08-04BTS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884522008792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452200879210884522008792

GMDN Terms#

Term, Definition table
TermDefinition
Endobronchial tubeA hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge39French
Device Size Text, specify0
Length13Millimeter

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
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
10884521038967ValleylabE250510FRNSB2025-03-27
10884524002880ValleylabE250510FRNSB2025-03-27
10884521039100ValleylabE3310NSB2016-09-24
10884521141117WarmTouch50308902019-02-06
10884521205024Shiley4CN65R2016-09-24
10884521205420Shiley5CN70R2016-09-24
10884521205437Shiley6CN75R2016-09-24
10884521205444Shiley7CN80R2016-09-24
10884521205451Shiley8CN85R2016-09-24
10884521205468Shiley9CN90R2016-09-24
10884521205475Shiley10CN10R2016-09-24
10884521205482Shiley4UN65R2016-09-24
10884521205499Shiley5UN70R2016-09-24
10884521205505Shiley6UN75R2016-09-24
10884521205512Shiley7UN80R2016-09-24
10884521205529Shiley8UN85R2016-09-24
10884521205536Shiley9UN90R2016-09-24
10884521205543Shiley10UN10R2016-09-24
10884521815360NellcorMAXFAST2021-08-09
10884521815469NellcorMAXFASTI2021-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521831780ShileyCovidien LPBTS2023-03-30
20884521831787ShileyCovidien LPBTS2023-03-30
10884521831674ShileyCovidien LPBTS2023-02-20
10884521831681ShileyCovidien LPBTS2023-02-20
20884521831671ShileyCovidien LPBTS2023-02-20
20884521831688ShileyCovidien LPBTS2023-02-20
10884521831667ShileyCovidien LPBTS2023-02-19
20884521831664ShileyCovidien LPBTS2023-02-19
10884521831650ShileyCovidien LPBTS2023-02-18
20884521831657ShileyCovidien LPBTS2023-02-18
10884521831537ShileyCovidien LPBTS2023-02-16
20884521831534ShileyCovidien LPBTS2023-02-16
10884521831544ShileyCovidien LPBTS2023-02-06
10884521831551ShileyCovidien LPBTS2023-02-06
10884521831575ShileyCovidien LPBTS2023-02-06
10884521831582ShileyCovidien LPBTS2023-02-06
10884521831773ShileyCovidien LPBTS2023-02-06
10884521831797ShileyCovidien LPBTS2023-02-06
10884521831803ShileyCovidien LPBTS2023-02-06
10884521831568ShileyCovidien LPBTS2023-02-05
10884522008785ShileyCovidien LPBTS2018-03-21
10884522008808ShileyCovidien LPBTS2018-03-21
10884522028950ShileyCovidien LPBTS2018-03-21
10884522028967MallinckrodtCovidien LPBTS2018-03-21
10884522028974ShileyCovidien LPBTS2018-03-21
20884522008775ShileyCovidien LPBTS2018-03-21
20884522028933ShileyCovidien LPBTS2018-03-21
40884522008717ShileyCovidien LPBTS2018-03-21
40884522008724ShileyCovidien LPBTS2018-03-21
40884522008748ShileyCovidien LPBTS2018-03-21