ECLERIS NIV HELMET U1VNI1001

GUDID B366U1VNI1001

ECLERIS NIV HELMET

Ecleris

In-line CPAP set, non-nebulizing In-line CPAP set, non-nebulizing In-line CPAP set, non-nebulizing In-line CPAP set, non-nebulizing In-line CPAP set, non-nebulizing In-line CPAP set, non-nebulizing In-line CPAP set, non-nebulizing In-line CPAP set, non-nebulizing

• Primary Device ID: B366U1VNI1001
• NIH Device Record Key: c4c2e4da-cf83-481f-be9a-29bb9cb8fff8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECLERIS NIV HELMET
• Version Model Number: R00
• Catalog Number: U1VNI1001
• Company DUNS: 043555079
• Company Name: Ecleris
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B366U1VNI1001 [Primary]

FDA Product Code

• FOG: Hood, Oxygen, Infant

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-08
• Device Publish Date: 2022-06-30

Devices Manufactured by Ecleris

• B366U1OM200CLR01 - MICROSCOPE: 2024-02-20 MICROSCOPE
• B366U1OM200CR01 - MICROSCOPE: 2024-02-20 MICROSCOPE
• B366U1OM200TLR01 - MICROSCOPE: 2024-02-20 MICROSCOPE
• B366U1OM200TR01 - MICROSCOPE: 2024-02-20 MICROSCOPE
• B366U1OM200WLR01 - MICROSCOPE: 2024-02-20 MICROSCOPE
• B366U1OM200WR01 - MICROSCOPE: 2024-02-20 MICROSCOPE
• B366U1C200FR00 - MICROSCOPE Colposcope: 2024-02-15 Colposcope w/ Floor Stand & Pantographic Arm
• B366U1C200TR00 - MICROSCOPE Colposcope: 2024-02-15 Colposcope w/ Table Mount & Pantographic Arm