SleepWeaver 3D Mask and Large Headgear - Blue 101491

GUDID B036101544

SleepWeaver 3D Mask and Large Headgear - Blue

CIRCADIANCE, LLC

CPAP/BPAP nasal mask, reusable
Primary Device IDB036101544
NIH Device Record Key8f21cfc3-e4b1-43cf-ab5f-aa1f85d7abd6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSleepWeaver 3D Mask and Large Headgear - Blue
Version Model Number101491
Catalog Number101491
Company DUNS012721295
Company NameCIRCADIANCE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-825-9640
Emailinfo@circadiance.com
Phone1-888-825-9640
Emailinfo@circadiance.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB036101491 [Primary]
HIBCCB036101544 [Package]
Contains: B036101491
Package: Box of 100 [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-28

Devices Manufactured by CIRCADIANCE, LLC

B036100274 - SleepWeaver Advance - Mask & Headgear - Blue2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Blue
B036100277 - SleepWeaver Advance - Mask & Headgear - Pink2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Pink
B036100281 - SleepWeaver Advance - Mask & Headgear - Camo2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Camo
B036100285 - SleepWeaver Advance - Mask & Headgear - Leopard2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Leopard
B036100289 - SleepWeaver Advance - Mask Only - Blue2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask Only - Blue
B036100291 - SleepWeaver Advance - Mask Only - Pink2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask Only - Pink
B036100293 - SleepWeaver Advance - Mask Only - Camo2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask Only - Camo
B036100295 - SleepWeaver Advance - Mask Only - Leopard2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask Only - Leopard

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