Home GUDID M9505030690 Transcend
Primary DI M9505030690
Brand Transcend
Company SOMNETICS INTERNATIONAL, INC.
Model EZEX Unit
Catalog number 503069
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name BZD Ventilator, Non-Continuous (Respirator)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BZD Ventilator, Non-Continuous (Respirator) Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M9505030690 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Home CPAP unit A 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.
Device Sizes# Type, Value, Unit table Type Value Unit Height 95 Millimeter Length 190 Millimeter Width 105 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature -20 Degrees Celsius 60 Degrees Celsius Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 047069263 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M9505050340 Transcend Micro WhisperSoft Muffler - S 505034 2024-01-31 M9505050010 Transcend Micro PowerAway Battery 505001 2024-01-31 M9505050170 Transcend Micro PureFresh 505017 2024-01-31 M9505050330 Transcend Micro WhisperSoft Muffler - C 505033 2024-01-31 M9505060010 Transcend Micro CPAP 506001 2023-08-22 M950503119 Transcend AirFlex 4 503119 2022-08-03 M950503120 Transcend AirFlex 6 503120 2022-08-03 M950503121 Transcend WhisperSoft 4 503121 2022-08-03 M950503122 Transcend WhisperSoft 6 503122 2022-08-03 M950503123 Transcend WhisperSoft 4 503123 2022-08-03 M950503124 Transcend WhisperSoft 6 503124 2022-08-03 M950505002 Transcend WhisperSoft 505002 2022-08-03 M950505003 Transcend WhisperSoft Micro 505003 2022-08-03 M950505004 Transcend AirFlex Micro 6 505004 2022-08-03 M950505025 Transcend WhisperSoft Micro 4 505025 2022-08-03 M950505026 Transcend WhisperSoft Micro 6 505026 2022-08-03 M950505027 Transcend AirFlex Micro 4 505027 2022-08-03 M950505028 Transcend WhisperSoft Micro 4 505028 2022-08-03 M950505029 Transcend WhisperSoft Micro 6 505029 2022-08-03 M9505030230 Transcend P8 Battery 503023 2019-01-03
Other Devices Sharing Product Codes# 
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