FDA.reportPublic FDA data

CPAP Masks

Primary DI
00848530097561
Brand
CPAP Masks
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
CM205M
Device description
Sunset Sol Full Face CPAP Mask with Medium Frame and Cushion, Headgear and SHS Labeled Bag
Published
2024-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)Anesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203347000Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow MaskSuzhou Yuyue Medical Technology Co., Ltd.2021-07-02BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530097561PrimaryGS10
10848530097568Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530097561008485300975618485300975610848530097561
1084853009756810848530097568

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, reusableA flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
10
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530109127Oxygen, Bacteria & HEPA FilterOF1001BR2026-06-23
00848530109134Oxygen, Bacteria & HEPA FilterOF1005BR2026-06-23
00848530109172Oxygen, Bacteria & HEPA FilterOF11006BR2026-06-23
00848530109189Oxygen, Bacteria & HEPA FilterOF3002BR2026-06-23
00848530109196Oxygen, Bacteria & HEPA FilterOF5001BR2026-06-23
00848530109202Oxygen, Bacteria & HEPA FilterOF6001BR2026-06-23
00848530109219Oxygen, Bacteria & HEPA FilterOF8002BR2026-06-23
00848530109226Oxygen, Bacteria & HEPA FilterOF9001BR2026-06-23
00848530109233Oxygen, Bacteria & HEPA FilterOF9002BR2026-06-23
00848530109240Oxygen, Bacteria & HEPA FilterOF9004BR2026-06-23
00848530109257Oxygen, Bacteria & HEPA FilterBF2200BR2026-06-23
00848530109110Suction KitRES026S-KITC2026-06-10
00848530107451Stratus Power SwitchRP0762025-09-24
00848530107468Stratus Pneumatic ValveRP0772025-09-24
00848530108984CPAP MaskCM206SNH2026-06-04
00848530108991CPAP MaskCM206MNH2026-06-04
00848530109004CPAP MaskCM206LNH2026-06-04
00848530109042CPAP MaskCM207SNH2026-06-04
00848530109059CPAP MaskCM207MNH2026-06-04
00848530109066CPAP MaskCM207LNH2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840178704122ITDTouchpoint Medical, Inc.BZN2026-07-07
00840456206768JMUJMU DENTAL, INCBZN2026-06-23
00840456206775JMUJMU DENTAL, INCBZN2026-06-23
00840178704801ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704818ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704825ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704832ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704849ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704702ITDTouchpoint Medical, Inc.BZN2026-05-14
00840178704658ITDTouchpoint Medical, Inc.BZN2026-05-07
06972077026419ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-05-07
06972077026426ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-05-07
G035X1BT70M0MULTIX SOLUTIONS SRLMULTIX SOLUTIONS SRLBZN2026-04-28
00840178704627ITDTouchpoint Medical, Inc.BZN2026-04-13
06972077025955ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
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06972077026082ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026099ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026105ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26