FDA.reportPublic FDA data

DeVilbiss

Primary DI
00885304000266
Brand
DeVilbiss
Company
DEVILBISS HEALTHCARE LLC
Model
9352sr
Catalog number
9352sr
Device description
Serenity Mask, ComfortTouch, Silicone - Small
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00885304000266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885304000266008853040002668853040002660885304000266

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, single-useA non-sterile, 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 single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-338-1988somdhccustomerservice@devilbisshc.com

Regulatory Flags#

DUNS number
962175894
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
00885304032045DeVilbiss125D-XB125D-XB2024-12-16
00885304033219DeVilbiss125D-BT 125D-BT 2025-04-28
00885304033226DeVilbiss125D-BT-XB125D-BT-XB2025-04-28
00885304033240DeVilbiss125D-BT-XB125D-BT-XB2025-04-28
00885304033257DeVilbiss125D-BT 125D-BT 2025-04-28
00885304033516DeVilbiss125D-ARYA-XB125D-ARYA-XB2025-04-28
00885304000105DeVilbiss7310P-6037310P-6032024-11-08
00885304032557DeVilbiss7325D-D-EXF7325D-D-EXF2024-11-08
00885304032571DeVilbiss7325P-D-EXF7325P-D-EXF2024-11-08
00885304001676DeVilbiss3655PL-VA3655PL-VA2016-09-08
00885304022268DeVilbiss3655I3655I-AR2017-04-21
10885304001505DeVilbiss3655PL-JCMH Case3655PL-JCMH2016-09-07
00885304020882DeVilbissDV64EDV64E2016-09-23
00885304000044DeVilbissDV54NE-PDV54NE-P2016-09-23
00885304000082DeVilbiss1751752016-09-24
00885304000884DeVilbiss5650C5650C2016-09-14
00885304022480DeVilbiss1025UK1025UK2017-08-17
00853040002806DeVilbiss9354DR9354DR2016-09-24
00853040015080DeVilbiss3655PL-JCMH3655PL-JCMH2016-09-09
00853040023382DeVilbiss7305D-D7305D-D2016-09-14

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