Nasal Jet Tube

GUDID 16944932776224

Well Lead Medical Co.,Ltd

Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use Nasopharyngeal airway, single-use

• Primary Device ID: 16944932776224
• NIH Device Record Key: fba7c779-3409-46a8-8d8c-4e3aede3b516
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nasal Jet Tube
• Version Model Number: A06A065010
• 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	06944932776227 [Primary]
GS1	16944932776224 [Package]; Contains: 06944932776227; Package: Box [10 Units]; In Commercial Distribution
GS1	26944932776221 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211543

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: 2022-08-18
• Device Publish Date: 2022-08-10

On-Brand Devices [Nasal Jet Tube]

• 16944932776262: 30Fr
• 16944932776248: 26Fr
• 16944932776224: A06A065010