ECLERIS NIV HELMET U1VNI1001

GUDID B366U1VNI1001

ECLERIS NIV HELMET

Ecleris

In-line CPAP set, non-nebulizing
Primary Device IDB366U1VNI1001
NIH Device Record Keyc4c2e4da-cf83-481f-be9a-29bb9cb8fff8
Commercial Distribution StatusIn Commercial Distribution
Brand NameECLERIS NIV HELMET
Version Model NumberR00
Catalog NumberU1VNI1001
Company DUNS043555079
Company NameEcleris
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone786-483-7490
Emailytzielo@ecleris.com
Phone786-483-7490
Emailytzielo@ecleris.com
Phone786-483-7490
Emailytzielo@ecleris.com
Phone786-483-7490
Emailytzielo@ecleris.com
Phone786-483-7490
Emailytzielo@ecleris.com
Phone786-483-7490
Emailytzielo@ecleris.com
Phone786-483-7490
Emailytzielo@ecleris.com
Phone786-483-7490
Emailytzielo@ecleris.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB366U1VNI1001 [Primary]

FDA Product Code

FOGHood, Oxygen, Infant

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-08
Device Publish Date2022-06-30

Devices Manufactured by Ecleris

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B366U1RH1011 - R-FLOWMETER2024-08-26 COMPUTERIZED FLOWMETER
B366FE1021RX1 - FNS-32002024-08-19 Laringoscope Non Rigid 3,2 mm.
B366FE1022RX1 - FNS-28002024-08-19 Laringoscope Non Rigid 2,8 mm.
B366U1OM200FLR01 - MICROSCOPE2024-08-02 MICROSCOPE
B366U1OM200FR01 - MICROSCOPE2024-08-02 MICROSCOPE
B366U1VI2021R01 - PROCAM HD 2D2024-07-26 PROCAM HD 2D
B366VN1061 - VNG 3D2024-05-28 VIDEONISTAGMOGRAPHY SYSTEM

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