Lightning X Products, Inc

GUDID 16946430423037

Berman airway is used to establish the airway and prevent the tongue fall and the airway block.

XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Oropharyngeal airway, single-use

• Primary Device ID: 16946430423037
• NIH Device Record Key: 9c2215dc-8a5a-4143-bd57-867b714db96f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lightning X Products, Inc
• Version Model Number: S40 /S60 /S80/S90 /S100 /S110
• Company DUNS: 543482946
• Company Name: XIAMEN COMPOWER MEDICAL TECH. CO., LTD
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06946430423030 [Primary]
GS1	16946430423037 [Package]; Contains: 06946430423030; Package: carton [100 Units]; In Commercial Distribution

FDA Product Code

• CAE: Airway, Oropharyngeal, Anesthesiology

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: 2025-06-23
• Device Publish Date: 2025-06-14

On-Brand Devices [Lightning X Products, Inc]

• 16946430413663: Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital
• 16946430423037: Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
• 16946430423013: It is designed to assist in providing immediate life support (mouth to mask ventilation) to heal