FDA.reportPublic FDA data

Somnera Headgear

Primary DI
30810045450019
Brand
Somnera Headgear
Company
FRESCA MEDICAL, INC.
Model
S1
Catalog number
28639
Device description
Headgear for use with the Somnera 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
30810045450019PrimaryGS10
00810045450018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081004545001930810045450019
00810045450018008100454500188100454500180810045450018

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
30810045450002Somnera ValveV1156922020-12-28
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
30810045450002Somnera ValveFRESCA 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