Instant Hand Antiseptic
Alcohol
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004824601 | 3004824601 | ASP Global, LLC | 1 | Y | 2026-01-01 | 7800 Third Flag Pkwy Austell GA US 30168 |
| 3015392401 | 3015392401 | ASP Global Manufacturing GmbH | 1 | N | 2026-01-01 | Im Majorenacker 10 SCHAFFHAUSEN CH 8207 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 291056 | 1834868600 | K991999 | STERRAD 100S STERILIZER | MLR | 2000-06-15 |
| 64041 | 1180403103 | K983517 | SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM | JKA | 1998-11-12 |
| 64041 | 1879702187 | K981973 | SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM | JKA | 1998-09-03 |
| 64041 | 2028917817 | K941802 | OR TOWEL | KKX | 1995-05-03 |
| 291056 | 1146037432 | K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) | FRC | 2024-12-12 |
| 291056 | 2001220231 | K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | QKM | 2024-04-05 |
| 291056 | 1779485158 | K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) | FRC | 2023-02-28 |
| 291056 | 1102758100 | K200272 | Terragene Chemdye | JOJ | 2020-06-30 |
| 291056 | 2070955450 | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye | FRC | 2019-09-13 |
| 291056 | 1943372035 | K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor | FEB | 2019-04-23 |
| 291056 | 1300725240 | K163646 | Terragene 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 Incubator | FRC | 2017-11-02 |
| 291056 | 1449483644 | K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator | KCT | 2017-07-31 |
| 64041 | 1176988855 | K163518 | Digital Thermometer | FLL | 2017-09-19 |
| 291056 | 1820249017 | K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | MLR | 2016-09-26 |
| 291056 | 1139076008 | K160818 | STERRAD® NX Sterilizer with ALLClear™ Technology | MLR | 2016-09-27 |
| 64041 | 1281281636 | K153149 | Digital 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-36 | FLL | 2016-05-27 |
| 64041 | 2071719598 | K152690 | DISPOSABLE THERMOMETER PROBE SHEATHS | FLL | 2016-01-15 |
| 291056 | 1189690154 | K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | MLR | 2015-04-03 |
| 64041 | 1392964907 | K131558 | PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6 | DXN | 2013-08-30 |
| 64041 | 1096369465 | K130925 | AUTOMATIC BLOOD PRESSURE MONITOR | DXN | 2013-09-12 |
| 291056 | 1309170011 | K111377 | STERRAD(R) 100NX STERILIZER DUO CYCLE | MLR | 2012-09-13 |
| 64041 | 1971098791 | K110776 | DIGITAL THERMOMETER MT SERIES | FLL | 2011-08-24 |
| 64041 | 1187364126 | K101000 | WELLMIEN SURGICAL MASK | FXX | 2010-08-09 |
| 64041 | 1713102702 | K093757 | MD300C1 FINGERTIP PULSE OXIMETER | DQA | 2010-03-03 |
| 291056 | 1212537115 | K092622 | STERRAD 100NX STERILIZER EXPRESS CYCLE | MLR | 2011-03-04 |
| 64041 | 1531283644 | K092447 | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES | FLL | 2010-01-07 |
| 64041 | 1375125413 | K092245 | ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 | DXQ | 2009-10-28 |
| 64041 | 1595572747 | K090599 | MD300K1 PULSE OXIMETER | DQA | 2009-07-20 |
| 64041 | 1734666609 | K082641 | FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL | DQA | 2008-11-10 |
| 291056 | 1508546641 | K081427 | BROWNE OPA TEST STRIP | JOJ | 2008-06-11 |
| 64041 | 1567758904 | K071886 | SELF SEAL STERILIZATION POUCH | FRG | 2007-12-27 |
| 291056 | 1331967271 | K071385 | STERRAD 100NX STERILIZER | MLR | 2007-11-29 |
| 64041 | 1352289592 | K071081 | CONTACT LENS CASE | LRX | 2007-05-01 |
| 64041 | 1367515578 | K070371 | FINGERTIP PULSE OXIMETER MD300C | DQA | 2007-08-13 |
| 64041 | 1563934723 | K051699 | SEJOY, MODEL MT-403 | FLL | 2006-02-06 |
| 291056 | 1770522077 | K042116 | STERRAD NX STERILIZER | MLR | 2005-04-22 |
| 291056 | 1673180376 | K032959 | CIDEX OPA CONCENTRATE | MED | 2005-04-04 |
| 291056 | 1071047082 | K030004 | 0.55% ORTH-PHTHALALDEHYDE SOLUTION | MED | 2003-02-27 |
| 291056 | 1171513659 | K023290 | STERRAD 50 & STERRAD 100S STERILIZERS | FLF | 2003-04-03 |
| 64041 | 1928129731 | K020281 | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM | NHK | 2002-02-11 |
| 291056 | 1267102946 | DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) | QVB | 2024-07-12 |
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| 64041 | 1438611013 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MLR | 8 | 2016-09-27 |
| FLL | 6 | 2017-09-19 |
| FRC | 4 | 2024-12-12 |
| DQA | 4 | 2010-03-03 |
| JOJ | 2 | 2020-06-30 |
| DXN | 2 | 2013-09-12 |
| MED | 2 | 2005-04-04 |
| JKA | 2 | 1998-11-12 |
| QVB | 1 | 2024-07-12 |
| QKM | 1 | 2024-04-05 |
| FEB | 1 | 2019-04-23 |
| KCT | 1 | 2017-07-31 |
| FXX | 1 | 2010-08-09 |
| DXQ | 1 | 2009-10-28 |
| FRG | 1 | 2007-12-27 |
| LRX | 1 | 2007-05-01 |
| FLF | 1 | 2003-04-03 |
| NHK | 1 | 2002-02-11 |
| KKX | 1 | 1995-05-03 |
Alcohol
Benzalkonium Chloride
Benzalkonium Chloride
Alcohol
ALCOHOL
ALCOHOL
Sodium Monofluorophospate
Sodium Monofluorophosphate
Alcohol and Sodium Monofluorophospate
Alcohol
Alcohol and Sodium Monofluorophospate
ALCOHOL and SODIUM MONOFLUOROPHOSPHATE
ALCOHOL and SODIUM MONOFLUOROPHOSPHATE
Sodium Monofluorophospate
ALCOHOL and SODIUM MONOFLUOROPHOSPHATE
ALCOHOL and SODIUM MONOFLUOROPHOSPHATE
Sodium Monofluorophosphate
Benzalkonium Chloride and SODIUM MONOFLUOROPHOSPHATE
Benzalkonium Chloride and Sodium Monofluorophosphate
Benzalkonium Chloride and SODIUM MONOFLUOROPHOSPHATE
Alcohol and Sodium Monofluorophosphate
Alcohol and Sodium Monofluorophospate
Benzalkonium Chloride and SODIUM MONOFLUOROPHOSPHATE
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