FDA.reportPublic FDA data

Sunset Healthcare Solutions Central Warehouse

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30108349343010834934Sunset Healthcare Solutions Central Warehouse1Y2026-01-012725 Alft Lane Elgin IL US 60124

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2136311677274518K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)FMK2022-10-03
2136311690913582K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow MaskBZD2021-07-02
2136311912641471K201418Sunset Heated CPAP TubeBZE2021-01-29
2136311180985202K182906Portable Mesh NebulizerCAF2020-09-27
2136311157874956K151461Hybernite RTBZE2016-03-24
2136311128114451K132882ELECTRIC BREAST PUMPHGX2014-04-24
2136311181149959K121955COUGHASSIST T70 DEVICENHJ2012-12-14
2136311298724482K113544ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGERGZJ2012-07-27
2136311148122936K102626VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01JCX2010-11-12
2136311587401908K102483SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104CAH2011-09-13
2136311916422173K102120NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202CBK2011-08-12
2136311857806793K101136FISIO CHAMBER SPACENVP2011-01-28
2136311876500832K091272BESMED JET NEBULIZER BOTTLE SETCAF2009-11-10
2136311051394166K070371FINGERTIP PULSE OXIMETER MD300CDQA2007-08-13
2136311467880093K063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235BZD2007-02-23
2136311013101742
2136311028276961
2136311055394170
2136311065989196
2136311066692376
2136311086454402
2136311090461969
2136311098463269
2136311118949939
2136311146913693
2136311194779730
2136311208800352
2136311262402616
2136311311868014
2136311395903750
2136311437038350
2136311458477972
2136311475127595
2136311505134282
2136311511119009
2136311592970281
2136311604776619
2136311605799165
2136311717309220
2136311741130352
2136311745952752
2136311852560139
2136311859586928
2136311942970935
2136311951135830
2136311977486418
2136311984913279
2136312032356109
2136312058347870
2136311321578518
2136311393972544
2136311493134913
2136311536406691
2136311547324336
2136311641717688
2136311938837089

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZD32021-07-02
CAF32020-09-27
BZE22021-01-29
HGX22014-04-24
GZJ22012-07-27
CAH22011-09-13
DQA22007-08-13
FMK12022-10-03
NHJ12012-12-14
CBK12011-08-12
NVP12011-01-28
JCX12010-11-12