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 ID26922166510651
NIH Device Record Key7c125784-6f84-4215-af21-f98ac813808f
Commercial Distribution StatusIn Commercial Distribution
Brand NameYUWELL Sleep Apnea Breathing Therapy Mask
Version Model NumberYF-03 (S)
Company DUNS421307196
Company NameSuzhou Yuyue Medical Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106922166510657 [Primary]
GS126922166510651 [Package]
Contains: 06922166510657
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-25
Device Publish Date2021-10-15

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

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

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