Hanwell

GUDID 06975834950583

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 ID06975834950583
NIH Device Record Key1d591561-6f6d-41e2-9202-3d2faa6e8a82
Commercial Distribution StatusIn Commercial Distribution
Brand NameHanwell
Version Model NumberL
Company DUNS602709486
Company NameNingbo Hanyue Medical Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106975834950583 [Primary]

FDA Product Code

BYFMask, Oxygen, Low Concentration, Venturi

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06975834950583]

Moist Heat or Steam Sterilization


[06975834950583]

Moist Heat or Steam Sterilization


[06975834950583]

Moist Heat or Steam Sterilization


[06975834950583]

Moist Heat or Steam Sterilization


[06975834950583]

Moist Heat or Steam Sterilization


[06975834950583]

Moist Heat or Steam Sterilization


[06975834950583]

Moist Heat or Steam Sterilization


[06975834950583]

Moist Heat or Steam Sterilization


[06975834950583]

Moist Heat or Steam Sterilization


[06975834950583]

Moist Heat or Steam Sterilization


[06975834950583]

Moist Heat or Steam Sterilization


[06975834950583]

Moist Heat or Steam Sterilization


[06975834950583]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-08
Device Publish Date2023-10-31

On-Brand Devices [Hanwell]

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

Trademark Results [Hanwell]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HANWELL
HANWELL
79299352 not registered Live/Pending
Marshall Amplification plc
2020-10-28
HANWELL
HANWELL
79227820 5640036 Live/Registered
HANWELL SOLUTIONS LTD.
2017-11-28
HANWELL
HANWELL
79147268 4718577 Live/Registered
Marshall Amplification plc
2013-12-05

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