FDA.reportPublic FDA data

Shiley

Primary DI
30884521105564
Brand
Shiley
Company
Covidien LP
Model
5-18441
Catalog number
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
30884521105564PackageGS14In 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
Special Storage Condition, Specify00no UV;
Storage Environment Temperature32 Degrees Fahrenheit90 Degrees Fahrenheit

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
true
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
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
40884521105561ShileyCovidien 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