FDA.reportPublic FDA data

Shiley

Primary DI
10884521831674
Brand
Shiley
Company
Covidien LP
Model
125239
Device description
Endobronchial Tube Left with Carinal Hook;Endobronchial Suction Catheter;Endobronchial Tube Accessories
Published
2023-02-20
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
20884521831671PackageGS15In Commercial Distribution
10884521831674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452183167120884521831671
1088452183167410884521831674

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

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
10884521072657V-LocVLOCN306L2015-09-02
10884521705166SofsilkSS622G2017-06-27
10884521757714Maxon8886616523-22020-07-19
10884521099272Chemosite1200492015-10-22
10884521099289Chemosite1200892015-09-28
10884521099265Chemosite1200392015-10-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521831780ShileyCovidien LPBTS2023-03-30
20884521831787ShileyCovidien LPBTS2023-03-30
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
10884522008792ShileyCovidien 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