FDA.reportPublic FDA data

CPAP Headgear

Primary DI
00848530085902
Brand
CPAP Headgear
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
HG036
Device description
Replacement Headgear for Sunset Nasal Pillow Mask
Published
2025-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTKStrap, Head, Gas Mask

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTKStrap, Head, Gas MaskAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530085902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530085902008485300859028485300859020848530085902

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530108984CPAP MaskCM206SNH2026-06-04
00848530108991CPAP MaskCM206MNH2026-06-04
00848530109004CPAP MaskCM206LNH2026-06-04
00848530109042CPAP MaskCM207SNH2026-06-04
00848530109059CPAP MaskCM207MNH2026-06-04
00848530109066CPAP MaskCM207LNH2026-06-04
00848530109080CPAP HeadgearHG2062026-06-04
00848530109103CPAP HeadgearHG2072026-06-04
00848530108328Repair PartsRP0932026-06-03
00848530109097CPAP MaskCM060S2026-06-03
00848530109264CPAP MaskCM060M2026-06-03
00848530109271CPAP MaskCM060L2026-06-03
00848530109288CPAP MaskCM060XL2026-06-03
00848530108953Repair PartsRP1082026-06-02
00848530108960Repair PartsRP1092026-06-02
00848530108977Repair PartsRP1102026-06-02
00848530109011Repair PartsRP1112026-06-02
00848530109028Repair PartsRP1122026-06-02
00848530109035Repair PartRP1132026-06-02
00848530109073Repair PartsRP1142026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109080CPAP HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2026-06-04
00848530109103CPAP HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2026-06-04
10889483002742Mask HarnessSUNMED, LLCBTK2026-03-19
06922166514068HeadgearSuzhou Yuyue Medical Technology Co., Ltd.BTK2025-10-10
06922166513894HeadgearSuzhou Yuyue Medical Technology Co., Ltd.BTK2025-09-30
06978333140011OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06978333140028OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06978333140004OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06978333140035OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06946430423313CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
06946430423320CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
16946430423310CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
16946430423327CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
10889483606827AirLife™AIRLIFEBTK2025-03-03
10889483606841AirLife™AIRLIFEBTK2025-03-03
10889483606858AirLife™AIRLIFEBTK2025-03-03
10889483606865AirLife™AIRLIFEBTK2025-03-03
10889483606872AirLife™AIRLIFEBTK2025-03-03
10889483606896AirLife™AIRLIFEBTK2025-03-03
10889483606919AirLife™AIRLIFEBTK2025-03-03
30889483606821AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606845AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606852AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606869AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606876AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606890AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606913AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
00848530088743HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
00848530080396HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
10848530088740HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30