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NeoPAP Delivery Circuit Adapter & Sizing Chart

Primary DI
B0361078582
Brand
NeoPAP Delivery Circuit Adapter & Sizing Chart
Company
CIRCADIANCE, LLC
Model
1078582
Catalog number
1078582
Device description
NeoPAP Delivery Circuit Adapter & Sizing Chart
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103410000NEOPAP SYSTEMChildrens Medical Ventures, LLC2011-03-30BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0361074128PackageHIBCC20In Commercial Distribution
B0361078582PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal CPAP unitA 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.

Contacts#

Phone, Email table
PhoneEmail
1-888-825-9640info@circadiance.com

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 DIBrandModelCatalogPublished
B036101486SleepWeaver 3D Mask and Regular Headgear - Blue1014861014862017-03-28
B036101491SleepWeaver 3D Mask and Large Headgear - Blue1014911014912017-03-28
B0361078535NeoPAP Bonnet - XS107853510785352016-07-29
B0361078536NeoPAP Bonnet - S107853610785362016-07-29
B0361078537NeoPAP Bonnet - M107853710785372016-07-29
B0361078538NeoPAP Bonnet - L107853810785382016-07-29
B0361078539NeoPAP Bonnet - XL107853910785392016-07-29
B0361078611NeoPAP Cannula - XS107861110786112016-07-29
B0361078612NeoPAP Cannula - S107861210786122016-07-29
B0361078613NeoPAP Cannula - M107861310786132016-07-29
B0361078614NeoPAP Cannula - L107861410786142016-07-29
B0361078616NeoPAP Cannula - XL107861610786162016-07-29
B0361078668NeoPAP Mask - L107866810786682016-07-29
B036100274SleepWeaver Advance - Mask & Headgear - Blue1002741002742016-09-22
B036100277SleepWeaver Advance - Mask & Headgear - Pink1002771002772016-09-22
B036100281SleepWeaver Advance - Mask & Headgear - Camo1002811002812016-09-22
B036100285SleepWeaver Advance - Mask & Headgear - Leopard1002851002852016-09-22
B036100289SleepWeaver Advance - Mask Only - Blue1002891002892016-09-20
B036100291SleepWeaver Advance - Mask Only - Pink1002911002912016-09-20
B036100293SleepWeaver Advance - Mask Only - Camo1002931002932016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344011902HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011919HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011926HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011933HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011940HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011957HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011964HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
00848530109677CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
00848530109684CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
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