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
OTC
false
Sterile
false
Single use
false

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530109141Oxygen, Bacteria & HEPA FilterOF11003BR2026-06-30
00848530109165Oxygen, Bacteria & HEPA FilterOF11005BR2026-06-30
00848530109295Oxygen kitAATH006O2KIT2026-06-11
00848530109462Nasal CPAP MaskCM060-KITLNV2026-07-15
00848530109479Nasal CPAP MaskCM060L-NV2026-07-15
00848530109486Nasal CPAP MaskCM060XL-NV2026-07-15
00848530109523Oxygen KitAHOW001O2KIT2026-08-20
00848530109592Ventilator FilterVF010-12026-08-20
00848530109608Ventilator FilterVF010F-12026-08-20
00848530109639Nasal CPAP MaskCM060SNH2026-08-24
00848530109646Nasal CPAP MaskCM060MNH2026-08-24
00848530109653CPAP MaskCM061SNH2026-08-24
00848530109660CPAP MaskCM061MNH2026-08-24
00848530109691CPAP HeadgearHG060B2026-09-09
00848530109721OXYGEN CONNECTOR/ADAPTERRES019-1PL2026-09-09
00848530109738CPAP FilterCF1015NS2026-08-31
00848530109783Oxygen AccessoryPOCBAG-P22026-09-09
00848530109813AerosolTUB100-1FT15MM2026-09-09
00848530109820Ventilation AccessoryVEN008NS2026-09-09
00848530109837Ventilation AccessoryRES096MPNS2026-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840178704863ITDTouchpoint Medical, Inc.BZN2026-08-03
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
06972077025962ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025979ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025986ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025993ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026006ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026013ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026020ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026037ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026044ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026051ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026068ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026075ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026082ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026099ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26