SleepWeaver Advance Pediatric - Mask & Headgear - 101325

GUDID B036101325

SleepWeaver Advance Pediatric Cloth Nasal PAP Mask & Headgear - Blue

CIRCADIANCE, LLC

CPAP/BPAP nasal mask, reusable
Primary Device IDB036101325
NIH Device Record Keye8ed02e5-73e1-4b71-a7a1-e7653f6736dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSleepWeaver Advance Pediatric - Mask & Headgear -
Version Model Number101325
Catalog Number101325
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
HIBCCB036101325 [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

On-Brand Devices [SleepWeaver Advance Pediatric - Mask & Headgear - ]

B036101328SleepWeaver Advance Pediatric Cloth Nasal PAP Mask & Headgear - Leopard
B036101327SleepWeaver Advance Pediatric Cloth Nasal PAP Mask & Headgear - Camo
B036101326SleepWeaver Advance Pediatric Cloth Nasal PAP Mask & Headgear - Pink
B036101325SleepWeaver Advance Pediatric Cloth Nasal PAP Mask & Headgear - Blue
B036101324SleepWeaver Advance Pediatric Cloth Nasal PAP Mask & Headgear - Beige

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