FDA.reportPublic FDA data

Shiley

Primary DI
10884522008808
Brand
Shiley
Company
Covidien LP
Model
125241
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
10884522008808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452200880810884522008808

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
Length13.7Millimeter

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
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09
10884521837126ILLUMISITEILS-1000-CS2024-08-09
10884521837133ILLUMISITEILS-1000-CS2024-08-09
10884521837140ILLUMISITEILS-1000-CS2024-08-09
10884521837157ILLUMISITEILS-1000-CS2024-08-09
10884521842915ILLUMISITEILS-1000-CS2024-08-09
10884521837096ILLUMISITEILS-1000-CS2023-09-17
10884521199996superDimensionAAS00161-20RAAS00161-20R2016-09-24
10884521747425superDimensionPMB00667-012018-02-28
10884521747432superDimensionPMB00569-012018-02-28
10884521199989superDimensionAAS00161-202016-09-24
10884521747418superDimensionILS-0001-FN2018-02-28

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
10884522008792ShileyCovidien 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