FDA.reportPublic FDA data

Somnera Valve

Primary DI
30810045450002
Brand
Somnera Valve
Company
FRESCA MEDICAL, INC.
Model
V1
Catalog number
15692
Device description
The valve is a component of a positive airway pressure system mask.
Published
2020-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QBYPositive Airway Pressure System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBYPositive Airway Pressure SystemAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200698000Somnera SystemFresca Medical, Inc.2020-06-29QBY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30810045450002PrimaryGS10
00810045450001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081004545000230810045450002
00810045450001008100454500018100454500010810045450001

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9495423535info@somnera.com

Regulatory Flags#

DUNS number
068329904
Device count
25
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30810045450026Somnera BackstrapB1297732021-05-07
30810045450040Somnera PillowP1 (S)456012021-05-07
30810045450057Somnera PillowP1 (M)478292021-05-07
30810045450064Somnera PillowP1 (L)491452021-05-07
30810045450088Somnera Nasal MaskM1 (S)729202021-05-07
30810045450095Somnera Nasa MaskM1 (M)742112021-05-07
30810045450101Somnera Nasal MaskM1 (L)796482021-05-07
30810045450132Somnera Airbox Air Filter Pack19423194232021-05-07
00810045450025Somnera BackstrapB1297732021-05-07
00810045450049Somnera PillowP1 (S)456012021-05-07
00810045450056Somnera PillowP1 (M)478292021-05-07
00810045450063Somnera PillowP1 (L)491452021-05-07
00810045450087Somnera Nasal MaskM1 (S)729202021-05-07
00810045450094Somnera Nasa MaskM1 (M)742112021-05-07
00810045450100Somnera Nasal MaskM1 (L)796482021-05-07
00810045450131Somnera Airbox Air Filter Pack19423194232021-05-07
30810045450170Somnera System Nasal Mask94392943922020-12-29
30810045450019Somnera HeadgearS1286392020-12-28
30810045450033Somnera HoseH1396512020-12-28
30810045450071Somnera Nasal Pillow Fit KitP3456032020-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30810045450026Somnera BackstrapFRESCA MEDICAL, INC.QBY2021-05-07
30810045450040Somnera PillowFRESCA MEDICAL, INC.QBY2021-05-07
30810045450057Somnera PillowFRESCA MEDICAL, INC.QBY2021-05-07
30810045450064Somnera PillowFRESCA MEDICAL, INC.QBY2021-05-07
30810045450088Somnera Nasal MaskFRESCA MEDICAL, INC.QBY2021-05-07
30810045450095Somnera Nasa MaskFRESCA MEDICAL, INC.QBY2021-05-07
30810045450101Somnera Nasal MaskFRESCA MEDICAL, INC.QBY2021-05-07
30810045450132Somnera Airbox Air Filter PackFRESCA MEDICAL, INC.QBY2021-05-07
00810045450025Somnera BackstrapFRESCA MEDICAL, INC.QBY2021-05-07
00810045450049Somnera PillowFRESCA MEDICAL, INC.QBY2021-05-07
00810045450056Somnera PillowFRESCA MEDICAL, INC.QBY2021-05-07
00810045450063Somnera PillowFRESCA MEDICAL, INC.QBY2021-05-07
00810045450087Somnera Nasal MaskFRESCA MEDICAL, INC.QBY2021-05-07
00810045450094Somnera Nasa MaskFRESCA MEDICAL, INC.QBY2021-05-07
00810045450100Somnera Nasal MaskFRESCA MEDICAL, INC.QBY2021-05-07
00810045450131Somnera Airbox Air Filter PackFRESCA MEDICAL, INC.QBY2021-05-07
30810045450170Somnera System Nasal MaskFRESCA MEDICAL, INC.QBY2020-12-29
30810045450019Somnera HeadgearFRESCA MEDICAL, INC.QBY2020-12-28
30810045450033Somnera HoseFRESCA MEDICAL, INC.QBY2020-12-28
30810045450071Somnera Nasal Pillow Fit KitFRESCA MEDICAL, INC.QBY2020-12-28
30810045450118Somnera Nasal Mask Fit KitFRESCA MEDICAL, INC.QBY2020-12-28
30810045450163Somnera System Nasal PillowFRESCA MEDICAL, INC.QBY2020-12-28
00810045450001Somnera ValveFRESCA MEDICAL, INC.QBY2020-12-28
00810045450018Somnera HeadgearFRESCA MEDICAL, INC.QBY2020-12-28
00810045450032Somnera HoseFRESCA MEDICAL, INC.QBY2020-12-28
00810045450070Somnera Nasal Pillow Fit KitFRESCA MEDICAL, INC.QBY2020-12-28
00810045450117Somnera Nasal Mask Fit KitFRESCA MEDICAL, INC.QBY2020-12-28
00810045450162Somnera System Nasal PillowFRESCA MEDICAL, INC.QBY2020-12-28
00812277035377CuraplexBOUND TREE MEDICAL, LLCQBY2019-08-30
00812277034721CuraplexBOUND TREE MEDICAL, LLCQBY2019-01-31