NeoPAP Delivery Circuit Adapter & Sizing Chart 1078582

GUDID B0361074128

NeoPAP Delivery Circuit Adapter & Sizing Chart

CIRCADIANCE, LLC

Neonatal CPAP unit Neonatal CPAP unit

• Primary Device ID: B0361074128
• NIH Device Record Key: 82bdd832-809a-4011-b40d-3a8a3455b43b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoPAP Delivery Circuit Adapter & Sizing Chart
• Version Model Number: 1078582
• Catalog Number: 1078582
• 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: true
• 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: true
• 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	B0361074128 [Package]; Contains: B0361078582; Package: Single [20 Units]; In Commercial Distribution
HIBCC	B0361078582 [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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