FDA.reportPublic FDA data

Shiley

Primary DI
10884521831551
Brand
Shiley
Company
Covidien LP
Model
125035
Device description
Endobronchial Tube Left;Endobronchial Suction Catheter;Endobronchial Tube Accessories
Published
2023-02-06
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
10884521831551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452183155110884521831551

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 Gauge35French
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
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
10884521782648ValleylabE105202021-07-12
10884521703797Tri-Staple 2.0SIGCIR21XT2026-07-31
10884521703810Tri-Staple 2.0SIGCIR25XT2026-07-31
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26
10884521141742Endo GIAEGIARADXT2015-09-01
10884521703728Tri-Staple 2.0SIGCIR28MT2019-06-29
10884521703735Tri-Staple 2.0SIGCIR28XT2024-11-29
10884521703780Tri-Staple 2.0SIGCIR21MT2019-06-29

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
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