Headgear

GUDID 26922166511511

Headgear for YUWELL Sleep Apnea Breathing Therapy Mask (YP-01)

Suzhou Yuyue Medical Technology Co., Ltd.

Orthodontic chin cap/cup

• Primary Device ID: 26922166511511
• NIH Device Record Key: 6d16a98a-94dc-44e2-a680-aa8152a959db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Headgear
• Version Model Number: H5
• Company DUNS: 421307196
• Company Name: Suzhou Yuyue 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06922166511517 [Primary]
GS1	26922166511511 [Package]; Contains: 06922166511517; Package: Carton [20 Units]; In Commercial Distribution

FDA Product Code

• BTK: Strap, Head, Gas Mask

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: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [Headgear]

• 26922166511511: Headgear for YUWELL Sleep Apnea Breathing Therapy Mask (YP-01)
• 26922166511504: Headgear for YUWELL Sleep Apnea Breathing Therapy Mask (YF-02 & YN-03)