NeoPAP Customer Trial Pack

Basic Information

• Brand Name: NeoPAP Customer Trial Pack
• Primary DI: B0361078602
• Version / Model: 1078602
• Catalog Number: 1078602
• Company Name: CIRCADIANCE, LLC
• Labeler DUNS: 012721295
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 45
• Record Status: Published
• Publish Date: 2016-07-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: abf3d8ec-f7d6-40ec-96b6-cdfb8122e49c

Device Description

Model # 1078535 – DI # B0361078535 – NeoPAP Bonnet XS – Qty 3; Model # 1078536 – DI # B0361078536 – NeoPAP Bonnet S – Qty 3; Model # 1078537 – DI # B0361078537 – NeoPAP Bonnet M – Qty 3; Model # 1078538 – DI # B0361078538 – NeoPAP Bonnet L – Qty 2; Model # 1078539 – DI # B0361078539 – NeoPAP Bonnet XL – Qty 2; Model # 1110290 – DI # B0361110290 – NeoPAP Cannula XXS – Qty 2; Model # 1078611 – DI # B0361078611 – NeoPAP Cannula XS – Qty 2; Model # 1078612 – DI # B0361078612 – NeoPAP Cannula S – Qty 2; Model # 1078613 – DI # B0361078613 – NeoPAP Cannula M – Qty 2; Model # 1078614 – DI # B0361078614 – NeoPAP Cannula L – Qty 2; Model # 1078616 – DI # B0361078616 – NeoPAP Cannula XL – Qty 2; Model # 1078667 – DI # B0361078667 – NeoPAP Nasal Mask S – Qty 5; Model # 1078668 – DI # B0361078668 – NeoPAP Nasal Mask L – Qty 5; Model # 1078582 – DI # B0361078582 – NeoPAP Pressure Line & Sizing Kit – Qty 10

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61197	Neonatal CPAP unit	A mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) of a neonatal/infant patient via an attached nasal cannula or mask, using continuous positive airway pressure (CPAP) during spontaneous respiration. It is an electronic unit with controls, and may be used with compressed medical gas cylinders [e.g., air, oxygen (O2)] or include an O2 concentrator compartment; additional features (e.g., adjustable flow rates and O2 concentration, humidification) may be provided. It is primarily intended for use in a healthcare facility, especially in intensive and critical care settings.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B0361078602	HIBCC
Unit of Use	B03610786022	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K103410	000