Tenax Laser Resistant Endotracheal Tube

GUDID TG0055

Tenax Laser Resistant Endotracheal Tube 5.5mm I.D. x 8.6mm O.D. (26FR)

BRYAN MEDICAL, INC.

Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use

• Primary Device ID: TG0055
• NIH Device Record Key: bb332796-7314-4aee-9e67-7e01a5e6f45b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenax Laser Resistant Endotracheal Tube
• Version Model Number: TG0055
• Company DUNS: 160067273
• Company Name: BRYAN MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	TG0055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200761

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-28
• Device Publish Date: 2020-12-18

On-Brand Devices [Tenax Laser Resistant Endotracheal Tube]

• TG0070: Tenax Laser Resistant Endotracheal Tube 7.0mm I.D. x 10.6mm O.D. (32FR)
• TG0065: Tenax Laser Resistant Endotracheal Tube 6.5mm I.D. x 10.0mm O.D. (30FR)
• TG0060: Tenax Laser Resistant Endotracheal Tube 6.0mm I.D. x 9.3mm O.D. (28FR)
• TG0055: Tenax Laser Resistant Endotracheal Tube 5.5mm I.D. x 8.6mm O.D. (26FR)
• TG0050: Tenax Laser Resistant Endotracheal Tube 5.0mm I.D. x 7.9mm O.D. (24FR)