ToTXinCare

GUDID 06978579510043

A device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated into a patient; it may also include a teeth protector to prevent damage to the teeth or tube during intubation. It typically consists of straps, pinch rings, cloth ties, or Velcro bands and provides the advantage of easy readjustment of the tube without retaping or the use of safety pins. This is a single-use device.

Tongxin Home Care Industry (Shenzhen) Co., Limited

Endotracheal tube holder

• Primary Device ID: 06978579510043
• NIH Device Record Key: 11d16ca4-e36d-4bdb-b1f9-5bc2bc014345
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ToTXinCare
• Version Model Number: TX-1056
• Company DUNS: 620114188
• Company Name: Tongxin Home Care Industry (Shenzhen) Co., Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06978579510043 [Primary]

FDA Product Code

• CBH: Device, Fixation, Tracheal Tube

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-12
• Device Publish Date: 2025-06-04

On-Brand Devices [ToTXinCare]

• 06978579510043: A device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated int
• 06978579510036: A device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated int
• 06978579510029: A device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated int
• 06978579510012: A device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated int
• 06978579510074: TX-MV1041-7