NeoPAP Device - US 1076378

GUDID B0361076378

NeoPAP Device - US

CIRCADIANCE, LLC

Neonatal CPAP unit

• Primary Device ID: B0361076378
• NIH Device Record Key: 520e2a12-f88b-4369-90b6-8e6f87c6d76e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoPAP Device - US
• Version Model Number: 1076378
• Catalog Number: 1076378
• Company DUNS: 012721295
• Company Name: CIRCADIANCE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-825-9640
• Email: info@circadiance.com
• Phone: 1-888-825-9640
• Email: info@circadiance.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 800 KiloPascal and 1070 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 800 KiloPascal and 1070 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 800 KiloPascal and 1070 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 800 KiloPascal and 1070 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0361076378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103410

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-29

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• B036100281 - SleepWeaver Advance - Mask & Headgear - Camo: 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Camo
• B036100285 - SleepWeaver Advance - Mask & Headgear - Leopard: 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Leopard
• B036100289 - SleepWeaver Advance - Mask Only - Blue: 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask Only - Blue
• B036100291 - SleepWeaver Advance - Mask Only - Pink: 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask Only - Pink
• B036100293 - SleepWeaver Advance - Mask Only - Camo: 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask Only - Camo
• B036100295 - SleepWeaver Advance - Mask Only - Leopard: 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask Only - Leopard