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Mallinckrodt - 86100
Device Description
A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Inner Diameter, 9.0, mm; Outer Diameter, 12.1, mm;
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: BTR
Device Name: Tube, Tracheal (W/Wo Connector)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.5730
Third Party Flag: N
Medical Specialty: AN
Device IdentifiersDevice Id: 50884522000756
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 40884522000759
Package Quantity: 10
Package Discontinue Date: 12/16/2020 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: PACK_OR_INNER_PACK
Device Id: 40884522000759
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 60884522000753
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 50884522000756
Package Quantity: 10
Package Discontinue Date: 12/16/2020 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: CASE