CPAP Masks

GUDID 00850035116005

SnugellFLOW 310 Full Face CPAP Mask with Removable Cushion-No Headgear Small

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP face mask, reusable
Primary Device ID00850035116005
NIH Device Record Keycc114623-4e1e-4945-a546-d4981b168461
Commercial Distribution StatusIn Commercial Distribution
Brand NameCPAP Masks
Version Model NumberASNU001CM005SNH
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850035116005 [Primary]

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-02
Device Publish Date2024-07-25

On-Brand Devices [CPAP Masks]

00848530088903CPAP Kit
00850054929471Sunset Sol Full Face CPAP Mask with Large Frame and Cushion, and Headgear Bundle
00850054929464Sunset Sol Full Face CPAP Mask with Medium Frame and Cushion, and Headgear Bundle
00850054929457Sunset Sol Full Face CPAP Mask with Small Frame and Cushion, and Headgear Bundle
00850035116234SnugellFLOW 210 Nasal CPAP Mask with Removable Cushion, Headgear - Large
00850035116227SnugellFLOW 210 Nasal CPAP Mask with Removable Cushion, Headgear - Medium
00850035116203SnugellFLOW 310 Full Face Mask with Removable Cushion, Headgear - Large
00850035116197SnugellFLOW 310 Full Face Mask with Removable Cushion, Headgear - Medium
00850035116180SnugellFLOW 310 Full Face Mask with Removable Cushion, Headgear - Small
00850035116050SnugellFLOW 210 Nasal CPAP Mask with Removable Cushion - No Headgear - Large
00850035116043SnugellFLOW 210 Nasal CPAP Mask with Removable Cushion - No Headgear - Meduim`
00850035116029SnugellFLOW 310 Full Face CPAP Mask with Removable Cushion-No Headgear Large
00850035116012SnugellFLOW 310 Full Face CPAP Mask with Removable Cushion-No Headgear- Medium
00850035116005SnugellFLOW 310 Full Face CPAP Mask with Removable Cushion-No Headgear Small
00848530100285Sunset Sol Full Face CPAP Mask with Small Frame, HG-Clips and Cushion
00848530100278Sunset Sol Full Face CPAP Mask with Medium Frame, HG-Clips and Cushion
00848530100261Sunset Sol Full Face CPAP Mask with Large Frame, HG-Clips and Cushion
00848530097950Sunset Full Face Mask, Standard Elbow, with Standard Headgear, Large-each
00848530097943Sunset Full Face Mask, Standard Elbow, with Standard Headgear, Medium-each
00848530097936Sunset Full Face Mask, Standard Elbow, with Standard Headgear, Small-each
00848530097929Sunset Full Face Mask, Single Limb Elbow Vented, with Standard Headgear, Large-each
00848530097912Sunset Full Face Mask, Single Limb Elbow Vented, with Standard Headgear, Medium-each
00848530097905Sunset Full Face Mask, Single Limb Elbow Vented, with Standard Headgear, Small-each
00848530097899Sunset Full Face Mask, Single Limb Elbow, with Standard Headgear, Large-each
00848530097882Sunset Full Face Mask, Single Limb Elbow, with Standard Headgear, Medium-each
00848530097875Sunset Full Face Mask, Single Limb Elbow, with Standard Headgear, Small-each
00848530097868Sunset Full Face Mask, Standard Elbow, with Cap Style Headgear, Large-each
00848530097851Sunset Full Face Mask, Standard Elbow, with Cap Style Headgear, Medium-each
00848530097844Sunset Full Face Mask, Standard Elbow, with Cap Style Headgear, Small-each
00848530097837Sunset Full Face Mask, Single Limb Elbow Vented, with Cap Style Headgear, Large-each
00848530097820Sunset Full Face Mask, Single Limb Elbow Vented, with Cap Style Headgear, Medium-each
00848530097813Sunset Full Face Mask, Single Limb Elbow Vented, with Cap Style Headgear, Small-each
00848530097790Sunset Full Face Mask, Single Limb Elbow, with Cap Style Headgear, Medium-each
00848530097783Sunset Full Face Mask, Single Limb Elbow, with Cap Style Headgear, Small-each
10848530097575Sunset Sol Full Face CPAP Mask with Small Frame and Cushion, Headgear and SHS Labeled Bag
10848530097568Sunset Sol Full Face CPAP Mask with Medium Frame and Cushion, Headgear and SHS Labeled Bag
10848530097551Sunset Sol Full Face CPAP Mask with Large Frame and Cushion, Headgear and SHS Labeled Bag
20848530097350Sunset Nasal Mask with Standard Headgear, Large
20848530097343Sunset Nasal Mask with Standard Headgear, Medium
20848530097336Sunset Nasal Mask with Standard Headgear, Small
10848530097322Sunset Full Face Mask, Standard Elbow, with Standard Headgear, Large
10848530097315Sunset Full Face Mask, Standard Elbow, with Standard Headgear, Medium
10848530097308Sunset Full Face Mask, Standard Elbow, with Standard Headgear, Small
10848530097292Sunset Full Face Mask, Single Limb Elbow Vented, with Standard Headgear, Large
10848530097285Sunset Full Face Mask, Single Limb Elbow Vented, with Standard Headgear, Medium
10848530097278Sunset Full Face Mask, Single Limb Elbow Vented, with Standard Headgea
10848530097261Sunset Full Face Mask, Single Limb Elbow, with Standard Headgear, Large
10848530097254Sunset Full Face Mask, Single Limb Elbow, with Standard Headgear, Medium
10848530097247Sunset Full Face Mask, Single Limb Elbow, with Standard Headgear, Small
10848530097230Sunset Full Face Mask, Standard Elbow, with Cap Style Headgear, Large

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.