NeoPAP Customer Trial Pack 1078602

GUDID B0361078602

Model # 1078535 – DI # B0361078535 – NeoPAP Bonnet XS – Qty 3; Model # 1078536 – DI # B0361078536 – NeoPAP Bonnet S – Qty 3; Model # 1078537 – DI # B0

CIRCADIANCE, LLC

Neonatal CPAP unit Neonatal CPAP unit

• Primary Device ID: B0361078602
• NIH Device Record Key: abf3d8ec-f7d6-40ec-96b6-cdfb8122e49c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoPAP Customer Trial Pack
• Version Model Number: 1078602
• Catalog Number: 1078602
• Company DUNS: 012721295
• Company Name: CIRCADIANCE, LLC
• Device Count: 45
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0361078602 [Primary]
HIBCC	B03610786022 [Unit of Use]

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

Devices Manufactured by CIRCADIANCE, LLC

• B036100274 - SleepWeaver Advance - Mask & Headgear - Blue: 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Blue
• B036100277 - SleepWeaver Advance - Mask & Headgear - Pink: 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Pink
• 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