Well Lead Endotracheal Tube with Evacuation Lumen

GUDID 16944932729633

PVC Cuff 7.0

Well Lead Medical Co.,Ltd

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

• Primary Device ID: 16944932729633
• NIH Device Record Key: 7ab4c69e-999c-4c82-b160-ceb05bc313c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Well Lead Endotracheal Tube with Evacuation Lumen
• Version Model Number: A01F017010
• Company DUNS: 544811862
• Company Name: Well Lead Medical Co.,Ltd
• Device Count: 1
• DM Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944932729636 [Primary]
GS1	16944932729633 [Package]; Contains: 06944932729636; Package: Box [10 Units]; In Commercial Distribution
GS1	26944932729630 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110269

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: 2024-02-05
• Device Publish Date: 2024-01-27

On-Brand Devices [Well Lead Endotracheal Tube with Evacuation Lumen]

• 16944932737003: PVC Cuff 9.0
• 16944932730448: PVC Cuff 6.5
• 16944932730431: PVC Cuff 6.0
• 16944932729664: PVC Cuff 8.5
• 16944932729657: PVC Cuff 8.0
• 16944932729640: PVC Cuff 7.5
• 16944932729633: PVC Cuff 7.0