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CIRCADIANCE

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
B0361074121NeoPAP Cannula - M - 10786131-888-825-9640info@circadiance.com
B0361074123NeoPAP Cannula - L - 10786141-888-825-9640info@circadiance.com
B0361074124NeoPAP Cannula - XL - 10786161-888-825-9640info@circadiance.com
B0361074127NeoPAP Mask - L - 10786681-888-825-9640info@circadiance.com
B0361078667NeoPAP Mask - S - 10786671-888-825-9640info@circadiance.com
B0361110290NeoPAP Cannula - XXS - 11102901-888-825-9640info@circadiance.com
B0364002SmartMonitor 2 w/o Modem - 40021-888-825-9640info@circadiance.com
B0364003SmartMonitor 2 w/ Modem - 40031-888-825-9640info@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#

NeoPAP Customer Trial Pack - Model # 1078535 – DI # B0361078535 – NeoPAP Bonnet XS – Qty 3;Model # 1078536 – DI # B0361078536 – NeoPAP Bonnet S – Qty 3;Model # 1078537 – DI # B0361078537 – NeoPAP Bonnet M – Qty 3;Model # 1078538 – DI # B0361078538 – NeoPAP Bonnet L – Qty 2;Model # 1078539 – DI # B0361078539 – NeoPAP Bonnet XL – Qty 2;Model # 1110290 – DI # B0361110290 – NeoPAP Cannula XXS – Qty 2;Model # 1078611 – DI # B0361078611 – NeoPAP Cannula XS – Qty 2;Model # 1078612 – DI # B0361078612 – NeoPAP Cannula S – Qty 2;Model # 1078613 – DI # B0361078613 – NeoPAP Cannula M – Qty 2;Model # 1078614 – DI # B0361078614 – NeoPAP Cannula L – Qty 2;Model # 1078616 – DI # B0361078616 – NeoPAP Cannula XL – Qty 2;Model # 1078667 – DI # B0361078667 – NeoPAP Nasal Mask S – Qty 5;Model # 1078668 – DI # B0361078668 – NeoPAP Nasal Mask L – Qty 5;Model # 1078582 – DI # B0361078582 – NeoPAP Pressure Line & Sizing Kit – Qty 10

CIRCADIANCE, LLC

2016-07-29

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