Home GUDID 00810045450100 Somnera Nasal Mask
Primary DI 00810045450100
Brand Somnera Nasal Mask
Company FRESCA MEDICAL, INC.
Model M1 (L)
Catalog number 79648
Device description Somnera Nasal Mask for use with the Somnera Positive Airway Pressure System
Published 2021-05-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name QBY Positive Airway Pressure System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QBY Positive Airway Pressure System Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30810045450101 Primary GS1 0 00810045450100 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 30810045450101 30810045450101 00810045450100 00810045450100 810045450100 0810045450100
GMDN Terms# Term, Definition table Term Definition CPAP/BPAP nasal mask, single-use A 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 Type Low High Condition Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 55 Degrees Celsius
Regulatory Flags# DUNS number 068329904 Device count 25 DM exempt false Premarket exempt false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 30810045450026 Somnera Backstrap FRESCA MEDICAL, INC. QBY 2021-05-07 30810045450040 Somnera Pillow FRESCA MEDICAL, INC. QBY 2021-05-07 30810045450057 Somnera Pillow FRESCA MEDICAL, INC. QBY 2021-05-07 30810045450064 Somnera Pillow FRESCA MEDICAL, INC. QBY 2021-05-07 30810045450088 Somnera Nasal Mask FRESCA MEDICAL, INC. QBY 2021-05-07 30810045450095 Somnera Nasa Mask FRESCA MEDICAL, INC. QBY 2021-05-07 30810045450101 Somnera Nasal Mask FRESCA MEDICAL, INC. QBY 2021-05-07 30810045450132 Somnera Airbox Air Filter Pack FRESCA MEDICAL, INC. QBY 2021-05-07 00810045450025 Somnera Backstrap FRESCA MEDICAL, INC. QBY 2021-05-07 00810045450049 Somnera Pillow FRESCA MEDICAL, INC. QBY 2021-05-07 00810045450056 Somnera Pillow FRESCA MEDICAL, INC. QBY 2021-05-07 00810045450063 Somnera Pillow FRESCA MEDICAL, INC. QBY 2021-05-07 00810045450087 Somnera Nasal Mask FRESCA MEDICAL, INC. QBY 2021-05-07 00810045450094 Somnera Nasa Mask FRESCA MEDICAL, INC. QBY 2021-05-07 00810045450131 Somnera Airbox Air Filter Pack FRESCA MEDICAL, INC. QBY 2021-05-07 30810045450170 Somnera System Nasal Mask FRESCA MEDICAL, INC. QBY 2020-12-29 30810045450002 Somnera Valve FRESCA MEDICAL, INC. QBY 2020-12-28 30810045450019 Somnera Headgear FRESCA MEDICAL, INC. QBY 2020-12-28 30810045450033 Somnera Hose FRESCA MEDICAL, INC. QBY 2020-12-28 30810045450071 Somnera Nasal Pillow Fit Kit FRESCA MEDICAL, INC. QBY 2020-12-28 30810045450118 Somnera Nasal Mask Fit Kit FRESCA MEDICAL, INC. QBY 2020-12-28 30810045450163 Somnera System Nasal Pillow FRESCA MEDICAL, INC. QBY 2020-12-28 00810045450001 Somnera Valve FRESCA MEDICAL, INC. QBY 2020-12-28 00810045450018 Somnera Headgear FRESCA MEDICAL, INC. QBY 2020-12-28 00810045450032 Somnera Hose FRESCA MEDICAL, INC. QBY 2020-12-28 00810045450070 Somnera Nasal Pillow Fit Kit FRESCA MEDICAL, INC. QBY 2020-12-28 00810045450117 Somnera Nasal Mask Fit Kit FRESCA MEDICAL, INC. QBY 2020-12-28 00810045450162 Somnera System Nasal Pillow FRESCA MEDICAL, INC. QBY 2020-12-28 00812277035377 Curaplex BOUND TREE MEDICAL, LLC QBY 2019-08-30 00812277034721 Curaplex BOUND TREE MEDICAL, LLC QBY 2019-01-31
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