FDA.reportPublic FDA data

Mallinckrodt

Primary DI
10884521103627
Brand
Mallinckrodt
Company
Covidien LP
Model
5-18537
Device description
Esophageal Tracheal Airway with X-Ray Line,Double Lumen
Published
2015-08-28
Public version status
Update
Distribution status
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
20884521103624PackageGS14In Commercial Distribution
10884521103627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452110362420884521103624
1088452110362710884521103627

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 Gauge37French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose to 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
10884521141117WarmTouch50308902019-02-06
10884521205024Shiley4CN65R2016-09-24
10884521205420Shiley5CN70R2016-09-24
10884521205437Shiley6CN75R2016-09-24
10884521205444Shiley7CN80R2016-09-24
10884521205451Shiley8CN85R2016-09-24
10884521205468Shiley9CN90R2016-09-24
10884521205475Shiley10CN10R2016-09-24
10884521205482Shiley4UN65R2016-09-24
10884521205499Shiley5UN70R2016-09-24
10884521205505Shiley6UN75R2016-09-24
10884521205512Shiley7UN80R2016-09-24
10884521205529Shiley8UN85R2016-09-24
10884521205536Shiley9UN90R2016-09-24
10884521205543Shiley10UN10R2016-09-24
10884521815360NellcorMAXFAST2021-08-09
10884521815469NellcorMAXFASTI2021-08-09
10884521820890Mon-a-Therm900412023-05-29
10884521820906Mon-a-Therm900422023-05-29
10884521820913Mon-a-Therm900432023-05-29

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
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
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