Home GUDID B366U1VNI1001 ECLERIS NIV HELMET
Primary DI B366U1VNI1001
Brand ECLERIS NIV HELMET
Company Ecleris
Model R00
Catalog number U1VNI1001
Device description ECLERIS NIV HELMET
Published 2022-06-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name FOG Hood, Oxygen, Infant
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FOG Hood, Oxygen, Infant Anesthesiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B366U1VNI1001 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition In-line CPAP set, non-nebulizing A portable collection of devices intended to be connected to a medical gas supply to assist non-intubated ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It includes an in-line/gas-line CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a mouthpiece or face mask, and may include additional components (e.g., tubing, manometer gauge); it does not include a nebulizer. This is a single-patient, reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Handling Environment Humidity 35 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature 20 Degrees Celsius 30 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -30 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 043555079 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Contains natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860010778616 Amron Oxygen Treatment Hood Amron International, Inc. FOG 2024-12-30 00850052737009 Sea-Long Medical Hood Sea-Long Medical Systems LLC FOG 2024-11-21 00860010778609 Amron Oxygen Treatment Hood Amron International, Inc. FOG 2023-08-10 H67103001 DISPOSA-HOOD UTAH MEDICAL PRODUCTS, INC. FOG 2020-06-04 H67103011 DISPOSA-HOOD UTAH MEDICAL PRODUCTS, INC. FOG 2020-06-04 H67103021 DISPOSA-HOOD UTAH MEDICAL PRODUCTS, INC. FOG 2020-06-04 H67103051 DISPOSA-HOOD UTAH MEDICAL PRODUCTS, INC. FOG 2020-06-04 H6710305W1 DISPOSA-HOOD UTAH MEDICAL PRODUCTS, INC. FOG 2020-06-04 H67103081 DISPOSA-HOOD UTAH MEDICAL PRODUCTS, INC. FOG 2020-06-04 H67103131 DISPOSA-HOOD UTAH MEDICAL PRODUCTS, INC. FOG 2020-06-04 H67103141 DISPOSA-HOOD UTAH MEDICAL PRODUCTS, INC. FOG 2020-06-04 00350770928081 Bite Block Avanos Medical, Inc. FOG 2020-02-05 00350770928098 AVANOS Avanos Medical, Inc. FOG 2020-02-05
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