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CIRCADIANCE

Matched from indexed company URL: CIRCADIANCE, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30061826323006182632CIRCADIANCE1N2026-01-011010 Corporate Lane Export PA US 15632

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B036101486SleepWeaver 3D Mask and Regular Headgear - Blue - 1014861-888-825-9640info@circadiance.com
B036101491SleepWeaver 3D Mask and Large Headgear - Blue - 1014911-888-825-9640info@circadiance.com
B0361078535NeoPAP Bonnet - XS - 10785351-888-825-9640info@circadiance.com
B0361078536NeoPAP Bonnet - S - 10785361-888-825-9640info@circadiance.com
B0361078537NeoPAP Bonnet - M - 10785371-888-825-9640info@circadiance.com
B0361078538NeoPAP Bonnet - L - 10785381-888-825-9640info@circadiance.com
B0361078539NeoPAP Bonnet - XL - 10785391-888-825-9640info@circadiance.com
B0361078582NeoPAP Delivery Circuit Adapter & Sizing Chart - 10785821-888-825-9640info@circadiance.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
978831314460622K162905SleepWeaver 3D Nasal MaskBZD2017-03-15
978831359874158K151683SleepWeaver Advance Pediatric Nasal CPAP MaskBZD2016-04-05
978831318147365K130481SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASKBZD2013-05-24
978831851431366K120757SLEEPWEAVER ELAN NASAL CPAP MASKBZD2012-04-24
978832070232296K103410NEOPAP SYSTEMBZD2011-03-30
978831023616217K092362SLEEPWEAVER NASAL CPAP MASKBZD2009-11-02
978831041677162K092362SLEEPWEAVER NASAL CPAP MASKBZD2009-11-02
978831411902754K061256SMARTMONITOR 2PSNPF2006-08-02
978831300285944K032403SMARTMONITOR 2 PROFESSIONAL SERIES (PS)NPF2003-10-27
978831799264044K011597SMARTMONITOR 2, MODEL 4000FLS2002-01-11
978831906113440

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZD142017-03-15
NPF42006-08-02
FLS22002-01-11

PMN#

GUDID#

115 records. Showing 1-40. Next