SleepWeaver Elan - Mask Only - Large - Beige 100663

GUDID B036100663

SleepWeaver Elan Cloth Nasal PAP Mask Only - Large - Beige

CIRCADIANCE, LLC

CPAP/BPAP nasal mask, reusable
Primary Device IDB036100663
NIH Device Record Keya24ca19b-6c4e-484d-aa93-c52bb3b56b2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSleepWeaver Elan - Mask Only - Large - Beige
Version Model Number100663
Catalog Number100663
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
HIBCCB036100663 [Primary]

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 Date2016-09-22

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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