Home GUDID B0361078602 NeoPAP Customer Trial Pack
Primary DI B0361078602
Brand NeoPAP Customer Trial Pack
Company CIRCADIANCE, LLC
Model 1078602
Catalog number 1078602
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
Published 2016-07-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name BZD Ventilator, Non-Continuous (Respirator)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BZD Ventilator, Non-Continuous (Respirator) Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B0361078602 Primary HIBCC 0 B03610786022 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 012721295 Device count 45 Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B036101486 SleepWeaver 3D Mask and Regular Headgear - Blue 101486 101486 2017-03-28 B036101491 SleepWeaver 3D Mask and Large Headgear - Blue 101491 101491 2017-03-28 B0361078535 NeoPAP Bonnet - XS 1078535 1078535 2016-07-29 B0361078536 NeoPAP Bonnet - S 1078536 1078536 2016-07-29 B0361078537 NeoPAP Bonnet - M 1078537 1078537 2016-07-29 B0361078538 NeoPAP Bonnet - L 1078538 1078538 2016-07-29 B0361078539 NeoPAP Bonnet - XL 1078539 1078539 2016-07-29 B0361078582 NeoPAP Delivery Circuit Adapter & Sizing Chart 1078582 1078582 2016-07-29 B0361078611 NeoPAP Cannula - XS 1078611 1078611 2016-07-29 B0361078612 NeoPAP Cannula - S 1078612 1078612 2016-07-29 B0361078613 NeoPAP Cannula - M 1078613 1078613 2016-07-29 B0361078614 NeoPAP Cannula - L 1078614 1078614 2016-07-29 B0361078616 NeoPAP Cannula - XL 1078616 1078616 2016-07-29 B0361078668 NeoPAP Mask - L 1078668 1078668 2016-07-29 B036100274 SleepWeaver Advance - Mask & Headgear - Blue 100274 100274 2016-09-22 B036100277 SleepWeaver Advance - Mask & Headgear - Pink 100277 100277 2016-09-22 B036100281 SleepWeaver Advance - Mask & Headgear - Camo 100281 100281 2016-09-22 B036100285 SleepWeaver Advance - Mask & Headgear - Leopard 100285 100285 2016-09-22 B036100289 SleepWeaver Advance - Mask Only - Blue 100289 100289 2016-09-20 B036100291 SleepWeaver Advance - Mask Only - Pink 100291 100291 2016-09-20
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