FDA.reportPublic FDA data

Shiley

Primary DI
20884521831688
Brand
Shiley
Company
Covidien LP
Model
125241
Device description
Endobronchial Tube Left with Carinal Hook;Endobronchial Suction Catheter;Endobronchial Tube Accessories
Published
2023-02-20
Public version status
New
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
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
20884521831688PackageGS15Not in Commercial Distribution
10884521831681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452183168820884521831688
1088452183168110884521831681

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 Gauge41French
Device Size Text, specify0

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
10884521620193Shiley18775S2017-04-18
10884521620209Shiley18780S2017-01-06
10884521543805SigniaSIGADAPTSTND2017-08-08
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

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
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