FDA.reportPublic FDA data

00848530097806

Primary DI
00848530097806
Brand
00848530097806
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
CM041LEEC-1
Device description
Sunset Full Face Mask, Single Limb Elbow, with Cap Style Headgear, Large-each
Published
2024-07-29
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
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530097806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530097806008485300978068485300978060848530097806

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
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
09420012464699Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-19
04719893347258WellellWellell Inc.BZD2026-03-17
04719893347265WellellWellell Inc.BZD2026-03-17
04719893347272WellellWellell Inc.BZD2026-03-17
24710810084946N/AGALEMED CORPORATIONBZD2026-03-05
44710810089747N/AGALEMED CORPORATIONBZD2026-03-05
44710810115620N/AGALEMED CORPORATIONBZD2026-03-05
44710810115637N/AGALEMED CORPORATIONBZD2026-03-05
44710810109636N/AGALEMED CORPORATIONBZD2026-03-05
44710810109643N/AGALEMED CORPORATIONBZD2026-03-05
44710810109650N/AGALEMED CORPORATIONBZD2026-03-05
44710810119666N/AGALEMED CORPORATIONBZD2026-03-05
44710810110175N/AGALEMED CORPORATIONBZD2026-03-05
44710810112452N/AGALEMED CORPORATIONBZD2026-03-05
00814747024676Arie Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-03-04
00814747024683Arie Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-03-04
00814747024690Arie Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-03-04
00814747024706Arie Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-03-04
00814747024713Arie Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-03-04
00814747024720Arie Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-03-04
00814747024737Arie Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-03-04
00814747024744Arie Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-03-04
10848530108356Vented CPAP Masks SUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-03-03
10848530108363Vented CPAP Masks SUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-03-03
10848530108370Vented CPAP Masks SUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-03-03
10848530108387Vented CPAP Masks SUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-03-03
16948538340162Siesta Contour Nasal MaskBMC Medical Co., Ltd.BZD2026-02-02
16948538340179Siesta Contour Nasal MaskBMC Medical Co., Ltd.BZD2026-02-02
16948538340186Siesta Contour Nasal MaskBMC Medical Co., Ltd.BZD2026-02-02
16948538340193Siesta Contour Nasal MaskBMC Medical Co., Ltd.BZD2026-02-02