YUWELL Sleep Apnea Breathing Therapy Mask

GUDID 26922166510651

YF-03 Full Face Mask - small, for single-patient use.

Suzhou Yuyue Medical Technology Co., Ltd.

CPAP/BPAP face mask, reusable

• Primary Device ID: 26922166510651
• NIH Device Record Key: 7c125784-6f84-4215-af21-f98ac813808f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YUWELL Sleep Apnea Breathing Therapy Mask
• Version Model Number: YF-03 (S)
• Company DUNS: 421307196
• Company Name: Suzhou Yuyue Medical Technology 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06922166510657 [Primary]
GS1	26922166510651 [Package]; Contains: 06922166510657; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203347

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

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: 2021-10-25
• Device Publish Date: 2021-10-15

On-Brand Devices [YUWELL Sleep Apnea Breathing Therapy Mask]

• 26922166510675: YF-03 Full Face Mask - large, for single-patient use.
• 26922166510668: YF-03 Full Face Mask - medium, for single-patient use.
• 26922166510651: YF-03 Full Face Mask - small, for single-patient use.
• 26922166510620: YF-02 Full Face Mask - large, for single-patient use.
• 26922166510613: YF-02 Full Face Mask - medium, for single-patient use.
• 26922166510606: YF-02 Full Face Mask - small, for single-patient use.
• 06922166510596: YF-01 Full Face Mask - large, for single-patient use.
• 26922166510583: YF-01 Full Face Mask - medium, for single-patient use.
• 26922166510576: YF-01 Full Face Mask - small, for single-patient use.
• 06922166510565: YN-03 Nasal Mask - large, for single-patient use.
• 26922166510552: YN-03 Nasal Mask - medium, for single-patient use.
• 26922166510545: YN-03 Nasal Mask - small, for single-patient use.
• 26922166510538: YN-02 Nasal Mask - large, for single-patient use.
• 26922166510521: YN-02 Nasal Mask - medium, for single-patient use.
• 26922166510514: YN-02 Nasal Mask - small, for single-patient use.
• 06922166510244: YP-01 Nasal Pillows Mask - large, medium, small. All size kit. For single-patient use.
• 26922166510804: YN-02 Nasal Mask-Large, include extra five cushions
• 26922166510798: YN-02 Nasal Mask-Medium, include extra five cushions
• 26922166510781: YN-02 Nasal Mask-Small, include extra five cushions
• 26922166510774: YF-01 Full Face Mask-Large, include extra two cushions
• 26922166510767: YF-01 Full Face Mask-Medium, include extra two cushions
• 26922166510750: YF-01 Full Face Mask-Small, include extra two cushions
• 26922166510743: YN-02 Nasal Mask Parts, Cushion (Large)
• 26922166510736: YN-02 Nasal Mask Parts, Cushion (Medium)
• 26922166510729: YN-02 Nasal Mask Parts, Cushion (Small)
• 26922166510712: YF-01 Full Face Mask Parts, Cushion (Large)
• 26922166510705: YF-01 Full Face Mask Parts, Cushion (Medium)
• 26922166510699: YF-01 Full Face Mask Parts, Cushion (Small)
• 26922166511092: YP-01 Nasal Pillows Mask Parts, Cushion (Large)
• 26922166511085: YP-01 Nasal Pillows Mask Parts, Cushion (Medium)
• 06922166511074: YP-01 Nasal Pillows Mask Parts, Cushion (Small)
• 26922166511061: YN-03 Nasal Mask Parts, Cushion (Large)
• 26922166511054: YN-03 Nasal Mask Parts, Cushion (Medium)
• 26922166511047: YN-03 Nasal Mask Parts, Cushion (Small)
• 26922166511030: YF-02 Full Face Mask Parts, Cushion (Large)
• 06922166511029: YF-02 Full Face Mask Parts, Cushion (Medium)
• 26922166511016: YF-02 Full Face Mask Parts, Cushion (Small)
• 26922166511443: YN-03 Nasal Mask Pack, include three frames, one headgear and three cushions (Small, Medium, Lar
• 26922166511436: YF-02 Full Face Mask Pack, include one frame, one headgear and three cushions (Small, Medium, La
• 26922166511498: YP-01 Nasal Pillows Mask-large, medium, small. All size kit without headgear. For single-patient
• 26922166511481: YN-03 Nasal Mask-Large, without headgear. For single-patient use.
• 26922166511474: YN-03 Nasal Mask-Medium, without headgear. For single-patient use.
• 26922166511467: YN-03 Nasal Mask-Small, without headgear. For single-patient use.
• 26922166511450: YF-02 Full Face Mask-Extra Large, without headgear. For single-patient use.
• 26922166511429: YF-02 Full Face Mask-Large, without headgear. For single-patient use.
• 26922166511412: YF-02 Full Face Mask-Medium, without headgear. For single-patient use.
• 06922166511401: YF-02 Full Face Mask-Small, without headgear. For single-patient use.