FDA.reportPublic FDA data

Sunset Nasal Mask with Standard Headgear, Medium, Non-Vented Elbow

Primary DI
10848530101265
Brand
Sunset Nasal Mask with Standard Headgear, Medium, Non-Vented Elbow
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
CM008MVNV-10
Device description
Sunset Nasal Mask with Standard Headgear, Medium, Non-Vented Elbow
Published
2024-03-04
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063268000CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235Hsiner Co., Ltd.2007-02-23BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530101265PackageGS110Not in Commercial Distribution
00848530101268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853010126510848530101265
00848530101268008485301012688485301012680848530101268

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, reusableA flexible, form-shaped device designed to be placed over a user's nose 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. 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
877-578-6738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
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
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
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109042CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109059CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109066CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00814747024850Novaplus Pediatric Nasal Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024867Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024874Novaplus Pediatric Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024881Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03
00814747024898Novaplus Pediatric Nasal Non Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024904Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024911Novaplus Pediatric Nasal Non Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024928Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03
00848530109097CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109264CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109271CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109288CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
04719893348873WellellWellell Inc.BZD2026-06-01
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