Hanwell

GUDID 06975834950576

Continuous Positive Airway Pressure (CPAP) mask provides the continuous positive airway pressure to treat obstructive sleep apnea(OSA), hypopnea, air flow restrictions and snoring. Made from medical grade Silicone, have good biocompatibility. Provide a good seal when fitted to the patient. Features a 360 degree dual swivel elbow port to move freely. The ultra-flexible forehead support reduces contact with your skin.

Ningbo Hanyue Medical Technology Co., Ltd.

CPAP/BPAP face mask, reusable

• Primary Device ID: 06975834950576
• NIH Device Record Key: 3e44fdaa-6977-4671-80d3-9bd5d5c564c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hanwell
• Version Model Number: M
• Company DUNS: 602709486
• Company Name: Ningbo Hanyue Medical Technology 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975834950576 [Primary]

FDA Product Code

• BYF: Mask, Oxygen, Low Concentration, Venturi

Sterilization

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

[06975834950576]

Moist Heat or Steam Sterilization

[06975834950576]

Moist Heat or Steam Sterilization

[06975834950576]

Moist Heat or Steam Sterilization

[06975834950576]

Moist Heat or Steam Sterilization

[06975834950576]

Moist Heat or Steam Sterilization

[06975834950576]

Moist Heat or Steam Sterilization

[06975834950576]

Moist Heat or Steam Sterilization

[06975834950576]

Moist Heat or Steam Sterilization

[06975834950576]

Moist Heat or Steam Sterilization

[06975834950576]

Moist Heat or Steam Sterilization

[06975834950576]

Moist Heat or Steam Sterilization

[06975834950576]

Moist Heat or Steam Sterilization

[06975834950576]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [Hanwell]

• 06975834950309: Adult
• 06975834950569: Continuous Positive Airway Pressure (CPAP) mask provides the continuous positive airway pressure
• 06975834950583: Continuous Positive Airway Pressure (CPAP) mask provides the continuous positive airway pressure
• 06975834950576: Continuous Positive Airway Pressure (CPAP) mask provides the continuous positive airway pressure