- Physicians Office Resource

Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff Non DEHP
Shiley - 86145

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

Cuff Resting,12.3,mm;Inner Diameter,4.5,mm;Distal Length (A),28,mm;Proximal Length 1 (B),44,mm;Proximal Length 2 (C),56,mm

Cuff Resting,12.3,mm;Inner Diameter,4.5,mm;Distal Length (A),28,mm;Proximal Length 1 (B),44,mm;Proximal Length 2 (C),56,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 Identifiers

Device Id: 30884521581948

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884521581941

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 20884521581941

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521581944

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PACK_OR_INNER_PACK

Device Id: 10884521581944

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

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