Dextrose
dextrose monohydrate
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1219611 | 1219611 | ICU Medical, Inc. | 1 | N | 2026-01-01 | 201 W Queen St SOUTHINGTON CT US 06489 |
| 1526863 | 1526863 | ICU Medical, Inc. | 1 | Y | 2026-01-01 | 6250 Shier Rings Rd DUBLIN OH US 43016 |
| 1824231 | 1824231 | ICU Medical, Inc. | 1 | N | 2026-01-01 | 5700 W 23rd Ave Gary IN US 46406 |
| 2024064 | 2024064 | ICU MEDICAL, INC. | 1 | N | 2026-01-01 | 13520 EVENING CREEK DRIVE NORTH SUITE 200 SAN DIEGO CA US 92128 |
| 2025816 | 2025816 | ICU MEDICAL, INC. | 1 | Y | 2026-01-01 | 951 CALLE AMANECER SAN CLEMENTE CA US 92673 |
| 3008818980 | 3008818980 | ICU Medical, Inc. | 1 | Y | 2026-01-01 | 9124 Polk Lane, Suite 101 Olive Branch MS US 38654 |
| 3012307300 | 3012307300 | ICU Medical, Inc. | 1 | N | 2026-01-01 | 6000 Nathan Lane North Minneapolis MN US 55442 |
| 3013319212 | 3013319212 | ICU MEDICAL, INC. | 1 | Y | 2026-01-01 | 600 N Field Dr Lake Forest IL US 60045 |
| 3027579175 | 3027579175 | ICU Medical, Inc. | 1 | N | 2026-01-01 | 2625 Main St Highland IN US 46322 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 195308 | 1341828718 | K994216 | PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM | LJT | 2000-01-27 |
| 5095 | 1237411934 | K993619 | CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK | BSP | 2000-04-28 |
| 195308 | 2018058014 | K993619 | CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK | BSP | 2000-04-28 |
| 195308 | 1439802466 | K993282 | IPI HUMIDIFIER CHAMBER | BTT | 2000-09-18 |
| 5095 | 1848962647 | K993282 | IPI HUMIDIFIER CHAMBER | BTT | 2000-09-18 |
| 5095 | 1512178777 | K992471 | SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 | BSO | 1999-10-22 |
| 195308 | 1917991059 | K992471 | SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 | BSO | 1999-10-22 |
| 195308 | 1005824893 | K991861 | 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE | BTM | 2000-01-18 |
| 5095 | 1352166644 | K991861 | 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE | BTM | 2000-01-18 |
| 204992 | 1325381676 | K991599 | CADD ADMINISTRATION SET | FPA | 1999-06-15 |
| 195308 | 1681795209 | K991599 | CADD ADMINISTRATION SET | FPA | 1999-06-15 |
| 195308 | 1461041451 | K991410 | 3402 HANDHELD PULSE OXIMETER | DQA | 1999-06-09 |
| 204992 | 1235647001 | K991301 | CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 | FPA | 1999-06-09 |
| 195308 | 1860768619 | K991301 | CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 | FPA | 1999-06-09 |
| 195308 | 1196458008 | K991300 | BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE | BWF | 1999-07-12 |
| 5095 | 1890015058 | K991300 | BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE | BWF | 1999-07-12 |
| 204992 | 1188921214 | K991255 | CADD-TPN ADMINISTRATION SET, MODEL 21-7071 | FPA | 1999-06-09 |
| 195308 | 2011113285 | K991255 | CADD-TPN ADMINISTRATION SET, MODEL 21-7071 | FPA | 1999-06-09 |
| 5095 | 1217676744 | K991086 | CAPNOCHECK II, MODEL 8400 | CCK | 1999-06-09 |
| 195308 | 1515587048 | K991086 | CAPNOCHECK II, MODEL 8400 | CCK | 1999-06-09 |
| 5095 | 1451179105 | K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | FOZ | 1999-08-20 |
| 9712 | 1920063715 | K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | FOZ | 1999-08-20 |
| 195308 | 1920063715 | K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | FOZ | 1999-08-20 |
| 195308 | 1142900606 | K990083 | CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER | FPA | 1999-02-12 |
| 204992 | 1827452551 | K990083 | CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER | FPA | 1999-02-12 |
| 195308 | 1768740827 | K984618 | BCI MINI-TORR PLUS, MODEL 6004 | DXN | 1999-03-25 |
| 5095 | 1932128208 | K984618 | BCI MINI-TORR PLUS, MODEL 6004 | DXN | 1999-03-25 |
| 195308 | 1037502154 | K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | MIA | 1999-01-29 |
| 5095 | 1281456224 | K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | MIA | 1999-01-29 |
| 5095 | 1013806164 | K983559 | BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR | FJK | 1998-12-24 |
| 5095 | 1122246169 | K983467 | THERAPEP | BWF | 1999-04-02 |
| 195308 | 1744617600 | K983467 | THERAPEP | BWF | 1999-04-02 |
| 195308 | 1610461533 | K982839 | CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 | MEA | 1998-11-02 |
| 204992 | 1794802334 | K982839 | CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 | MEA | 1998-11-02 |
| 204992 | 1954676240 | K982838 | CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 | FRN | 1998-11-04 |
| 195308 | 2034453463 | K982838 | CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 | FRN | 1998-11-04 |
| 204992 | 1486834503 | K982836 | CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM | FRN | 1998-11-02 |
| 195308 | 2026102971 | K982836 | CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM | FRN | 1998-11-02 |
| 195308 | 1006266763 | K982640 | MEDEX 3000 SERIES SYRINGE INFUSION PUMP | FRN | 1999-04-06 |
| 195308 | 1144607089 | K982279 | VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 | MHX | 1998-09-25 |
| 5095 | 1710544091 | K982279 | VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 | MHX | 1998-09-25 |
| 204992 | 1929412157 | K982159 | ABBOTT PLUM A+ INFUSION PUMP | FRN | 1999-01-12 |
| 195308 | 1140402662 | K982123 | CONTRAST CONTROL DEVICE | FPA | 1998-07-21 |
| 5095 | 1420689563 | K982123 | CONTRAST CONTROL DEVICE | FPA | 1998-07-21 |
| 195308 | 1495833225 | K981939 | AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR | DQA | 1998-08-20 |
| 9703 | 1778137830 | K981167 | STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT | CAF | 1998-06-18 |
| 195308 | 1778137830 | K981167 | STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT | CAF | 1998-06-18 |
| 195308 | 1670817701 | K980714 | BCI 3401 HANDHELD PULSE OXIMETER | DQA | 1998-03-25 |
| 5095 | 1828806894 | K980714 | BCI 3401 HANDHELD PULSE OXIMETER | DQA | 1998-03-25 |
| 195308 | 2027462765 | K980662 | LICHEN, BACTERIAL IN LINE BREATHING FILTER | CAH | 1998-09-14 |
| 5095 | 1623545722 | K974697 | REUSABLE FINGER SENSOR 3444 | DQH | 1998-03-11 |
| 195308 | 1982467241 | K974697 | REUSABLE FINGER SENSOR 3444 | DQH | 1998-03-11 |
| 195308 | 1636879771 | K974471 | PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A | LJT | 1998-01-22 |
| 195308 | 1101222824 | K974013 | EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE | FPA | 1997-12-17 |
| 195308 | 1075157535 | K973917 | CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM | FRN | 1998-01-09 |
| 204992 | 1884633167 | K973917 | CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM | FRN | 1998-01-09 |
| 195308 | 1158646350 | K973532 | STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR | CAF | 1998-03-19 |
| 5095 | 1345509445 | K973532 | STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR | CAF | 1998-03-19 |
| 204992 | 1321191901 | K971293 | LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE | FPA | 1997-06-27 |
| 204992 | 1734500013 | K970855 | CLAVE CONNECTOR | FPA | 1997-06-24 |
| 5095 | 1394387308 | K970785 | SIMS HYPERINFLATION BAG SYSTEM | NHK | 1997-06-13 |
| 195308 | 1877432159 | K970785 | SIMS HYPERINFLATION BAG SYSTEM | NHK | 1997-06-13 |
| 5095 | 1466210208 | K970596 | DHD EMERALD PRODUCT | BWF | 1997-05-16 |
| 195308 | 1904826023 | K970596 | DHD EMERALD PRODUCT | BWF | 1997-05-16 |
| 5095 | 1266309880 | K970209 | CAPNOCHECK PLUS | CCK | 1997-04-18 |
| 195308 | 1637388961 | K970209 | CAPNOCHECK PLUS | CCK | 1997-04-18 |
| 195308 | 1908896866 | K970158 | BABYPAC | CBK | 1998-04-28 |
| 5095 | 1984225761 | K970158 | BABYPAC | CBK | 1998-04-28 |
| 5095 | 1345434478 | K965017 | REGIONAL ANESTHESIA TRAYS | CAZ | 1997-03-14 |
| 195308 | 1463683401 | K965017 | REGIONAL ANESTHESIA TRAYS | CAZ | 1997-03-14 |
| 5095 | 1525850981 | K964435 | PRIMARY IV SET | FMG | 1997-04-02 |
| 195308 | 1388564608 | K962695 | PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER | LJT | 1996-10-01 |
| 5095 | 1438806232 | K962695 | PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER | LJT | 1996-10-01 |
| 195308 | 1400306125 | K962534 | THERA-MIST NEBULIZER MODEL-P3000 | CAF | 1997-02-28 |
| 195308 | 1319084508 | K962175 | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE | JOH | 1997-01-17 |
| 195308 | 1147756846 | K962156 | 3304 PULSE OXIMETER | DQA | 1996-08-28 |
| 5095 | 1487733814 | K962156 | 3304 PULSE OXIMETER | DQA | 1996-08-28 |
| 195308 | 1058694866 | K961973 | DHD ACE WITH MASK KIT | CAF | 1996-08-15 |
| 5095 | 1020897815 | K961580 | PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS | LJT | 1996-09-20 |
| 195308 | 1692553713 | K961580 | PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS | LJT | 1996-09-20 |
| 204992 | 1408985809 | K961552 | CVP POLYURETHANE CATHETER | FOZ | 1997-02-10 |
| 5095 | 1458493170 | K961404 | MX960 REUSABLE PRESSURE TRANSDUCER | DRS | 1996-06-27 |
| 9703 | 1532066572 | K961404 | MX960 REUSABLE PRESSURE TRANSDUCER | DRS | 1996-06-27 |
| 195308 | 1532066572 | K961404 | MX960 REUSABLE PRESSURE TRANSDUCER | DRS | 1996-06-27 |
| 195308 | 1520808512 | K961318 | 1ST RESPONSE DISPOSABLE MANOMETER | CAP | 1996-12-17 |
| 5095 | 1532786422 | K961318 | 1ST RESPONSE DISPOSABLE MANOMETER | CAP | 1996-12-17 |
| 195308 | 1491837871 | K960957 | EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK | FRN | 1996-06-04 |
| 204992 | 2021872704 | K960957 | EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK | FRN | 1996-06-04 |
| 195308 | 1213069984 | K960826 | CADD-PRIZM MODEL 6100 PUMP | FRN | 1996-08-23 |
| 204992 | 1346843457 | K960826 | CADD-PRIZM MODEL 6100 PUMP | FRN | 1996-08-23 |
| 5095 | 1307732865 | K960515 | PARAPAC | BTL | 1996-10-10 |
| 195308 | 1979505141 | K960515 | PARAPAC | BTL | 1996-10-10 |
| 195308 | 1522440007 | K955407 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS | LJT | 1996-02-12 |
| 5095 | 1139274659 | K954970 | STOPCOCK & LUER LOCK PLUG | FMG | 1996-04-22 |
| 195308 | 1223307886 | K954970 | STOPCOCK & LUER LOCK PLUG | FMG | 1996-04-22 |
| 9703 | 1223307886 | K954970 | STOPCOCK & LUER LOCK PLUG | FMG | 1996-04-22 |
| 5095 | 1256513299 | K954813 | ICU EXTENSION KIT | FPA | 1995-11-29 |
| 9711 | 1585171659 | K954429 | KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT | KNT | 1996-03-08 |
| 195308 | 1489090357 | K954015 | ABG POINT LOK NEEDLE PROTECTION DEVICE | CBT | 1995-11-20 |
| 5095 | 1544055885 | K954015 | ABG POINT LOK NEEDLE PROTECTION DEVICE | CBT | 1995-11-20 |
| 5095 | 1216945752 | K953483 | SIMS BLUE LINE ENDOBRONCHIAL TUBE | CBI | 1995-10-24 |
| 195308 | 1660136286 | K953483 | SIMS BLUE LINE ENDOBRONCHIAL TUBE | CBI | 1995-10-24 |
| 5095 | 1385336097 | K953206 | DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION) | CAF | 1995-08-28 |
| 195308 | 1855858755 | K953206 | DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION) | CAF | 1995-08-28 |
| 195308 | 1534353242 | K953126 | OXILINK (SMALL, MEDIUM, LARGE) | DQA | 1995-09-21 |
| 204972 | 1057512610 | K952799 | ABBOTT XL3M INFUSION PUMP | FRN | 1996-01-18 |
| 204992 | 1057512610 | K952799 | ABBOTT XL3M INFUSION PUMP | FRN | 1996-01-18 |
| 5095 | 1660361601 | K952516 | PRO-VENT, LINE DRAW, PULSATOR | JKA | 1995-07-14 |
| 195308 | 1993280565 | K952516 | PRO-VENT, LINE DRAW, PULSATOR | JKA | 1995-07-14 |
| 9712 | 1993280565 | K952516 | PRO-VENT, LINE DRAW, PULSATOR | JKA | 1995-07-14 |
| 195308 | 1377688870 | K952214 | SIMS INTERTECH HYPERINFLATION BAG SYSTEM | NHK | 1995-06-08 |
| 5095 | 2063828679 | K952214 | SIMS INTERTECH HYPERINFLATION BAG SYSTEM | NHK | 1995-06-08 |
| 195308 | 1068527526 | K952169 | SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC | BTM | 1995-06-08 |
| 5095 | 1440278324 | K952160 | INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) | FPA | 1995-09-21 |
| 9703 | 1637069047 | K952160 | INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) | FPA | 1995-09-21 |
| 195308 | 1637069047 | K952160 | INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) | FPA | 1995-09-21 |
| 195308 | 1438000386 | K952062 | PFT FILTER | CAH | 1995-06-08 |
| 5095 | 2069113793 | K952062 | PFT FILTER | CAH | 1995-06-08 |
| 195308 | 1178007089 | K951805 | PIPER, MODEL NUMBER UDS-PIPERB | FEN | 1995-07-06 |
| 9703 | 1191351900 | K951129 | NOVATRANS II | DRS | 1995-04-05 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FPA | 83 | 2025-06-05 |
| FRN | 71 | 2025-04-02 |
| JOH | 61 | 2021-11-26 |
| DQA | 31 | 2009-05-01 |
| BTO | 30 | 2018-04-10 |
| LJT | 22 | 2010-03-01 |
| FMI | 19 | 2021-08-26 |
| DYB | 19 | 2019-07-25 |
| BTR | 19 | 2008-08-13 |
| CCK | 19 | 2003-08-19 |
| FOZ | 18 | 2016-06-30 |
| CAF | 18 | 2004-04-02 |
| DRS | 15 | 2017-11-09 |
| MEA | 15 | 2017-08-24 |
| BTL | 15 | 2013-09-16 |
| CAH | 15 | 2004-05-13 |
| BWF | 14 | 2019-10-24 |
| FLL | 14 | 1992-09-11 |
| DWJ | 12 | 2018-07-26 |
| JKA | 12 | 2008-07-21 |
| BSP | 10 | 2018-06-12 |
| CAZ | 10 | 2012-09-14 |
| BTM | 10 | 2003-02-11 |
| FMG | 9 | 2009-02-25 |
| PHC | 8 | 2026-04-02 |
| CBT | 8 | 2007-08-01 |
| MRZ | 6 | 2017-08-25 |
| DQE | 6 | 2014-07-02 |
| LGZ | 6 | 2008-06-02 |
| FMF | 6 | 2008-05-02 |
| BSO | 6 | 2006-10-18 |
| LHI | 5 | 2025-01-22 |
| DQO | 5 | 2005-12-22 |
| FPB | 5 | 1986-04-09 |
| KPE | 5 | 1985-02-15 |
| QBP | 4 | 2020-03-06 |
| MIA | 4 | 2018-06-14 |
| MEG | 4 | 2007-02-27 |
| NHK | 4 | 1997-06-13 |
| CBP | 4 | 1988-10-07 |
Icu Medical, Inc.
Icu Medical, Inc.
Icu Medical, Inc.
Icu Medical, Inc.
ICU Medical, Inc.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
ICU MEDICAL, INC.
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