FDA.reportPublic FDA data

Mallinckrodt

Primary DI
20884522043363
Brand
Mallinckrodt
Company
Covidien LP
Model
86551
Device description
Oral/Nasal Tracheal Tube Cuffed,Reinforced, Murphy Eye
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, tracheal (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790575000TUBE, ARMORED TRACHEALNational Patent Development Corp.1979-04-13BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884522043363PackageGS15In Commercial Distribution
10884522043366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452204336320884522043363
1088452204336610884522043366

GMDN Terms#

Term, Definition table
TermDefinition
Laser-resistant endotracheal tubeA hollow cylinder that is inserted into the trachea used to secure airway patency and/or for anaesthesia administration, and which is not damaged or easily set on fire if inadvertently irradiated by a laser beam during surgery around the head, throat, or neck. This device would typically be employed when laser surgery is being applied to the patient's head/neck area. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

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10884521852273BIS AdvancePMC80CB2026-10-26
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10884521853836Shiley1108702026-10-25
10884521853843Shiley1108752026-10-25
10884521853850Shiley1108802026-10-25
10884521853867Shiley1108852026-10-25
10884521853874Shiley1108902026-10-25
10884521856547Touch SurgeryMDS300282026-10-23
10884521861114Vital SyncVITALSYNCSW032026-10-25
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10884521063433Ti-CronX-11362015-09-02
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521853812ShileyCovidien LPBTR2026-10-25
10884521853829ShileyCovidien LPBTR2026-10-25
10884521853836ShileyCovidien LPBTR2026-10-25
10884521853843ShileyCovidien LPBTR2026-10-25
10884521853850ShileyCovidien LPBTR2026-10-25
10884521853867ShileyCovidien LPBTR2026-10-25
10884521853874ShileyCovidien LPBTR2026-10-25
14026704934758LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934765LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934772LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934802LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704759191SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759399SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759405SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759412SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759429SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759436SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759443SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759481SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759498SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759504SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759511SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759566SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759573SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759597SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759696SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759740SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759580SHERIDANTELEFLEX INCORPORATEDBTR2026-07-29
00810003750822KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750839KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08