Mallinckrodt 96117

GUDID 60884522007448

Hi-Lo Oral/Nasal Tracheal Tube,Lanz System

Covidien LP

Basic endotracheal tube, single-use

• Primary Device ID: 60884522007448
• NIH Device Record Key: 90246bf4-bf62-4a3e-b86e-3943f47c82d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mallinckrodt
• Version Model Number: 96117
• Catalog Number: 96117
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes; Avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes; Avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Do not expose to UV;Avoid temperature extremes

Device Identifiers

Device Issuing Agency	Device ID
GS1	40884522007444 [Package]; Contains: 50884522007441; Package: PACK_OR_INNER_PACK [10 Units]; In Commercial Distribution
GS1	50884522007441 [Primary]
GS1	60884522007448 [Package]; Contains: 50884522007441; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791045

FDA Product Code

• BTR: Tube, tracheal (w/wo connector)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-31

On-Brand Devices [Mallinckrodt]

• 60884522004096: Intubating Stylet
• 70884522004086: Intubating Stylet
• 60884522004072: Intubating Stylet
• 50884522007328: Oral RAE Tracheal Tube Cuffed,Murphy Eye
• 40884522007314: Oral RAE Tracheal Tube Cuffed,Murphy Eye
• 50884522007304: Oral RAE Tracheal Tube Cuffed,Murphy Eye
• 50884522007298: Oral RAE Tracheal Tube Cuffed,Murphy Eye
• 50884522006383: Nasal RAE Tracheal Tube Cuffless,Murphy Eye
• 50884522006376: Nasal RAE Tracheal Tube Cuffless,Murphy Eye
• 40884522006362: Nasal RAE Tracheal Tube Cuffless,Murphy Eye
• 40884522006355: Nasal RAE Tracheal Tube Cuffless,Murphy Eye
• 50884522006345: Nasal RAE Tracheal Tube Cuffless,Murphy Eye
• 40884522006294: Oral RAE Tracheal Tube Cuffed,Murphy Eye
• 50884522006284: Oral RAE Tracheal Tube Cuffed,Murphy Eye
• 40884522006270: Oral RAE Tracheal Tube Cuffed,Murphy Eye
• 40884522006263: Microlaryngeal Oral/Nasal Tracheal Tube Cuffed,Murphy Eye
• 40884522006256: Microlaryngeal Oral/Nasal Tracheal Tube Cuffed,Murphy Eye
• 40884522006249: Microlaryngeal Oral/Nasal Tracheal Tube Cuffed,Murphy Eye
• 40884522005747: Oral/Nasal Tracheal Tube Cuffless,Murphy Eye
• 40884522005730: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
• 50884522005720: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
• 50884522005713: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
• 40884522005709: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
• 50884522005690: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
• 40884522005686: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
• 40884522005549: Oral/Nasal Tracheal Tube Cuffless
• 50884522005539: Oral/Nasal Tracheal Tube Cuffless
• 50884522005522: Oral/Nasal Tracheal Tube Cuffless
• 60884522005512: Oral/Nasal Tracheal Tube Cuffless
• 50884522005508: Oral/Nasal Tracheal Tube Cuffless
• 50884522005492: Oral/Nasal Tracheal Tube Cuffless
• 40884522005488: Oral/Nasal Tracheal Tube Cuffless
• 50884522005478: Oral/Nasal Tracheal Tube Cuffless
• 40884522005464: Oral/Nasal Tracheal Tube Cuffless
• 40884522005457: Oral/Nasal Tracheal Tube Cuffless
• 50884522005447: Oral/Nasal Tracheal Tube Cuffless
• 40884522005402: Lo-Pro Oral/Nasal Tracheal Tube Cuffed,Magill Tip
• 50884522000572: Oral/Nasal EMT Tracheal Tube Cuffed,Murphy Eye
• 50884522000565: Oral/Nasal EMT Tracheal Tube Cuffed,Murphy Eye
• 40884522000551: Oral/Nasal EMT Tracheal Tube Cuffed,Murphy Eye
• 50884522000541: Oral/Nasal EMT Tracheal Tube Cuffed,Murphy Eye
• 50884522000534: Oral/Nasal EMT Tracheal Tube Cuffed,Murphy Eye
• 50884522000527: Oral/Nasal EMT Tracheal Tube Cuffed,Murphy Eye
• 40884522000513: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
• 50884522000503: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
• 50884522000497: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
• 40884522000483: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
• 50884522000473: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
• 40884522000469: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
• 40884522000452: Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye