FDA.report

Headgear

Primary DI
00848530080396
Brand
Headgear
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
HG003RP
Device description
Universal Headgear
Published
2024-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BTKStrap, Head, Gas Mask

Product Code Classifications

CodeDeviceSpecialtyClass
BTKStrap, Head, Gas MaskAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848530080396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530080396008485300803968485300803960848530080396

GMDN Terms

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

Contacts

PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags

DUNS number
141668116
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00848530108618CPAP FilterF-1382026-03-19
00848530108632CPAP TubingTUBE-962026-03-19
00848530108472Oxygen, Bacteria & HEPA FilterBF027-102026-03-17
00848530108489CPAP FilterA11FILTER12PK2026-03-17
10848530108646Repair PartsRP0972026-03-17
00848530108656Repair PartsRP0982026-03-17
10848530108660Repair PartsRP0992026-03-17
10848530108677Repair PartsRP1002026-03-17
10848530108684Repair PartsRP1042026-03-17
10848530108189Repair PartsRP1032026-03-09
10848530108196Repair PartsRP1052026-03-09
10848530108202Oxygen, Bacteria & HEPA FilterOF7003-102026-03-09
10848530108219Oxygen, Bacteria & HEPA FilterOF7005-102026-03-09
00848530108571Repair PartsRP101NS2026-03-09
00848530108588Repair PartsRP102NS2026-03-09
10848530108356Vented CPAP Masks VC10092026-03-03
10848530108363Vented CPAP Masks VC10102026-03-03
10848530108370Vented CPAP Masks VC10112026-03-03
10848530108387Vented CPAP Masks VC10122026-03-03
00848530108427Ventilator FilterVF005-12026-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10889483002742Mask HarnessSUNMED, LLCBTK2026-03-19
00848530085902CPAP HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2025-11-12
06978333140004OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06978333140035OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
16946430423310CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
16946430423327CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
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
10848530088740HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
00848530098247CPAP MasksSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
00848530098254CPAP MasksSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
00848530099015Chin StrapSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
00848530100292HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
00848530080372Chin StrapSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-29
00848530090777Chin StrapSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-29
00848530090784Chin StrapSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-29
00850035116388Chin StrapSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-25
00848530091507HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-23
00848530080365CPAP Headgear ChinSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-15
00848530091491HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-15
00848530040468CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-09
00848530080112Chin StrapSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-09
04719871892237JBCFOREMOUNT ENTERPRISE CO., LTD.BTK2024-06-28
00848530090760Chin StrapSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-06-21
00850035116371CPAP KitSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-06-21