FDA.reportPublic FDA data

Shiley

Primary DI
40884521105561
Brand
Shiley
Company
Covidien LP
Model
5-18441
Device description
Esophageal Tracheal Airway, Rollup Kit, Double Lumen. Manufactured under license of Frass and Frenzer.
Published
2017-10-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAOAIRWAY, ESOPHAGEAL (OBTURATOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAOAirway, Esophageal (Obturator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K875226000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K875226000ESOPHAGEAL OBTURATOR/TRACHEAL TUBESheridan Catheter Corp.1988-01-19CAO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884521105564PackageGS14Not in Commercial Distribution
40884521105561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088452110556430884521105564
4088452110556140884521105561

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal-obturating/tracheal airway, single-useA two-lumen, semiflexible, single-use tube inserted blindly through the mouth into the oesophagus or trachea to maintain airway patency while obturating the oesophagus, typically during emergencies to facilitate breathing/resuscitation. The oesophageal-obturating lumen has a blocked distal end and perforations at the pharyngeal level. A large oropharyngeal balloon seals mouth and nose; a distal cuff seals either the oesophagus or the trachea. Ventilation starts via the oesophageal tube, if the tube is in the oesophagus air enters the pharynx via the perforations; when the tube is in the trachea the ventilation is performed directly through the tracheal tube. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge41French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No UV
Storage Environment Temperature32 Degrees Fahrenheit90 Degrees Fahrenheit

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
Contains natural rubber latex
true

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
00812277035384CuraplexBOUND TREE MEDICAL, LLCCAO2019-08-30
00812277035391CuraplexBOUND TREE MEDICAL, LLCCAO2019-08-30
00812277035407CuraplexBOUND TREE MEDICAL, LLCCAO2019-08-30
40884521105578ShileyCovidien LPCAO2018-05-16
30884521105571ShileyCovidien LPCAO2018-05-16
20884521103648ShileyCovidien LPCAO2018-05-13
30884521105564ShileyCovidien LPCAO2017-10-05
10884521211957ShileyCovidien LPCAO2017-05-22
30884521105557ShileyCovidien LPCAO2017-05-22
10884521211933ShileyCovidien LPCAO2017-05-10
30884521103638ShileyCovidien LPCAO2017-05-10
10884521211940ShileyCovidien LPCAO2017-05-09
40884521105530ShileyCovidien LPCAO2017-05-09
40884521105554ShileyCovidien LPCAO2017-03-22
30884521103621ShileyCovidien LPCAO2017-03-22
10884521103627MallinckrodtCovidien LPCAO2015-08-28
20884521103631MallinckrodtCovidien LPCAO2015-08-28
20884521105536MallinckrodtCovidien LPCAO2015-08-28
20884521105550MallinckrodtCovidien LPCAO2015-08-28
20884521105567MallinckrodtCovidien LPCAO2015-08-28
20884521105574MallinckrodtCovidien LPCAO2015-08-28
20884521103624MallinckrodtCovidien LPCAO2015-08-28
10884521103641MallinckrodtCovidien LPCAO2015-08-28
10884521103634MallinckrodtCovidien LPCAO2015-08-28
10884521105539MallinckrodtCovidien LPCAO2015-08-28
10884521105553MallinckrodtCovidien LPCAO2015-08-28
10884521105560MallinckrodtCovidien LPCAO2015-08-28
10884521105577MallinckrodtCovidien LPCAO2015-08-28