FDA.reportPublic FDA data

Somnera System Nasal Pillow

Primary DI
30810045450163
Brand
Somnera System Nasal Pillow
Company
FRESCA MEDICAL, INC.
Model
60942
Catalog number
60942
Device description
A positive airway pressure system for the treatment of obstructive sleep apnea. System consists of an airflow generator, mask, headgear, valve and hose.
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
30810045450163PrimaryGS10
00810045450162Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081004545016330810045450163
00810045450162008100454501628100454501620810045450162

GMDN Terms#

Term, Definition table
TermDefinition
Home CPAP unitA portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.

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
10
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
30810045450019Somnera HeadgearS1286392020-12-28
30810045450033Somnera HoseH1396512020-12-28

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
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
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