Home GUDID B036100782 SleepWeaver Elan - Mask & Headgear Starter Kit - Blue
Primary DI B036100782
Brand SleepWeaver Elan - Mask & Headgear Starter Kit - Blue
Company CIRCADIANCE, LLC
Model 100782
Catalog number 100782
Device description SleepWeaver Elan Cloth Nasal PAP Mask & Headgear Start Kit - Small/Regular/Large Cushions - Blue
Published 2016-09-22
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 B036100782 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition CPAP/BPAP nasal mask, reusable A flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.
Regulatory Flags# DUNS number 012721295 Device count 1 Lot or batch true No natural rubber latex 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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