FDA.reportPublic FDA data

Sunset Ruby Style Chin Strap - Medium

Primary DI
10848530040588
Brand
Sunset Ruby Style Chin Strap - Medium
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
CS007M
Catalog number
CS007M
Device description
Sunset Ruby Style Chin Strap - Medium
Published
2018-09-17
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

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
10848530040588PackageGS1100In Commercial Distribution
00848530040581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853004058810848530040588
00848530040581008485300405818485300405810848530040581

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia mask strap, reusableA band of material designed to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and often affixed to a special stabilizing device (e.g., with hooks) located on the gas connection port of the mask. It is typically used for anaesthesia of long duration. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@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 DI, Brand, Model table
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 DI, Brand, Company table
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
00848530080396HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
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