FDA.reportPublic FDA data

SleepWeaver 3D Mask and Large Headgear - Blue

Primary DI
B036101544
Brand
SleepWeaver 3D Mask and Large Headgear - Blue
Company
CIRCADIANCE, LLC
Model
101491
Catalog number
101491
Device description
SleepWeaver 3D Mask and Large Headgear - Blue
Published
2017-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K162905000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162905000SleepWeaver 3D Nasal MaskCircadiance, LLC2017-03-15BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B036101544PackageHIBCC100In Commercial Distribution
B036101491PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, reusableA 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
012721295
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
B0361078582NeoPAP Delivery Circuit Adapter & Sizing Chart107858210785822016-07-29
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344011889HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011896HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
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
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