ASP Global, LLC

Matched from indexed company URL: Asp Global, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30048246013004824601ASP Global, LLC1Y2026-01-017800 Third Flag Pkwy Austell GA US 30168
30153924013015392401ASP Global Manufacturing GmbH1N2026-01-01Im Majorenacker 10 SCHAFFHAUSEN CH 8207

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2910561834868600K991999STERRAD 100S STERILIZERMLR2000-06-15
640411180403103K983517SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEMJKA1998-11-12
640411879702187K981973SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEMJKA1998-09-03
640412028917817K941802OR TOWELKKX1995-05-03
2910561146037432K242453Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)FRC2024-12-12
2910562001220231K232103Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)QKM2024-04-05
2910561779485158K221641Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)FRC2023-02-28
2910561102758100K200272Terragene ChemdyeJOJ2020-06-30
2910562070955450K191021Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene ChemdyeFRC2019-09-13
2910561943372035K181472AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorFEB2019-04-23
2910561300725240K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorFRC2017-11-02
2910561449483644K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical IndicatorKCT2017-07-31
640411176988855K163518Digital ThermometerFLL2017-09-19
2910561820249017K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyMLR2016-09-26
2910561139076008K160818STERRAD® NX Sterilizer with ALLClear™ TechnologyMLR2016-09-27
640411281281636K153149Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36FLL2016-05-27
640412071719598K152690DISPOSABLE THERMOMETER PROBE SHEATHSFLL2016-01-15
2910561189690154K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerMLR2015-04-03
640411392964907K131558PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6DXN2013-08-30
640411096369465K130925AUTOMATIC BLOOD PRESSURE MONITORDXN2013-09-12
2910561309170011K111377STERRAD(R) 100NX STERILIZER DUO CYCLEMLR2012-09-13
640411971098791K110776DIGITAL THERMOMETER MT SERIESFLL2011-08-24
640411187364126K101000WELLMIEN SURGICAL MASKFXX2010-08-09
640411713102702K093757MD300C1 FINGERTIP PULSE OXIMETERDQA2010-03-03
2910561212537115K092622STERRAD 100NX STERILIZER EXPRESS CYCLEMLR2011-03-04
640411531283644K092447DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIESFLL2010-01-07
640411375125413K092245ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100DXQ2009-10-28
640411595572747K090599MD300K1 PULSE OXIMETERDQA2009-07-20
640411734666609K082641FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLDQA2008-11-10
2910561508546641K081427BROWNE OPA TEST STRIPJOJ2008-06-11
640411567758904K071886SELF SEAL STERILIZATION POUCHFRG2007-12-27
2910561331967271K071385STERRAD 100NX STERILIZERMLR2007-11-29
640411352289592K071081CONTACT LENS CASELRX2007-05-01
640411367515578K070371FINGERTIP PULSE OXIMETER MD300CDQA2007-08-13
640411563934723K051699SEJOY, MODEL MT-403FLL2006-02-06
2910561770522077K042116STERRAD NX STERILIZERMLR2005-04-22
2910561673180376K032959CIDEX OPA CONCENTRATEMED2005-04-04
2910561071047082K0300040.55% ORTH-PHTHALALDEHYDE SOLUTIONMED2003-02-27
2910561171513659K023290STERRAD 50 & STERRAD 100S STERILIZERSFLF2003-04-03
640411928129731K020281MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEMNHK2002-02-11
2910561267102946DEN220042Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)QVB2024-07-12
640411089568925
640411095459676
640411110182043
640411130135423
640411138675660
640411164052107
640411177765525
640411231523212
640411239629141
640411243916557
640411247803896
640411253008880
640411259064551
640411284990841
640411295854091
640411341874780
640411345934282
640411368598195
640411379842652
640411412900343
640411494467243
640411544926678
640411547593845
640411612830399
640411613352663
640411616270406
640411624782285
640411627834668
640411628582372
640411632371832
640411645099700
640411656640640
640411720796113
640411725069444
640411725160509
640411777375788
640411799647347
640411810320331
640411820286880
640411842778209
640411877429302
640411888111895
640411891387685
640411921834601
640411952044326
640411952895579
640412015496718
640412015806156
640412016484822
640412033092287
640412040309125
640412043837042
640412060224196
640412073233498
640411043028129
640411046730110
640411064147048
640411066178589
640411076032231
640411093465675
640411108085960
640411131442548
640411134841071
640411157004756
640411185844252
640411198431375
640411221664895
640411226491361
640411231175565
640411252622383
640411262772154
640411274068132
640411317225886
640411326498993
640411331782838
640411335539794
640411347166126
640411356156502
640411438611013

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MLR82016-09-27
FLL62017-09-19
FRC42024-12-12
DQA42010-03-03
JOJ22020-06-30
DXN22013-09-12
MED22005-04-04
JKA21998-11-12
QVB12024-07-12
QKM12024-04-05
FEB12019-04-23
KCT12017-07-31
FXX12010-08-09
DXQ12009-10-28
FRG12007-12-27
LRX12007-05-01
FLF12003-04-03
NHK12002-02-11
KKX11995-05-03

NDC#

GUDID#

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