Levetiracetam
Levetiracetam
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2521402 | 2521402 | B. BRAUN MEDICAL INC. | 1 | Y | 2026-01-01 | 824 12th Ave BETHLEHEM PA US 18018 |
| 3013764800 | 3013764800 | B. BRAUN MEDICAL INC. | 1 | N | 2026-01-01 | 861 Marcon Blvd. Allentown PA US 18109 |
| 1641965 | 1641965 | B. BRAUN MEDICAL INC. | 1 | N | 2020-04-25 | 1601 WALLACE DR., SUITE 150 CARROLLTON TX US 75006 |
| 2532083 | 3003218564 | B. BRAUN MEDICAL INC. | 1 | Y | 2020-04-25 | 200 BOULDER DR. BREINIGSVILLE PA US 18031 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 04046955114559 | IV Administration Set - IV ADMIN SET | +1(800)227-2862 | BBMUS_Service.EmailOrders@bbraun.com |
| 04046955765164 | IV Administration Set - IV ADMIN SET, 3 HI-FLOW 4-WAY STOPCOCKS | +1(800)227-2862 | BBMUS_Service.EmailOrders@bbraun.com |
| 04046955862658 | Design Options® - SANFORD USD MEDICAL CENTER | +1(800)227-2862 | BBMUS_Service.EmailOrders@bbraun.com |
| 04046955966233 | Design Options® - ALLINA HEALTH SPINAL EPIDURAL TRAY SESK | +1(800)227-2862 | BBMUS_Service.EmailOrders@bbraun.com |
| 04046955966370 | Design Options® - HEALTH PARTNERS-NERVE BLOCK SUPPORT TRAY | +1(800)227-2862 | BBMUS_Service.EmailOrders@bbraun.com |
| 04046961025153 | Prontosan® - PRONTOSAN SOL. OPS TWIST-OFF"US"1000ML | +1(800)227-2862 | BBMUS_Service.EmailOrders@bbraun.com |
| 04046964176968 | CONTIPLEX® - Contiplex® Tuohy Tray (Kit), 18 Ga. x 2 in. Insulated Needle and Non-Stimulating Catheter (CNB200TK) | +1(800)227-2862 | BBMUS_Service.EmailOrders@bbraun.com |
| 04046964176982 | CONTIPLEX® - Contiplex® Tuohy Tray (Kit), 18 Ga. x 4 in. Insulated Needle and Non-Stimulating Catheter (CNB400TK) | +1(800)227-2862 | BBMUS_Service.EmailOrders@bbraun.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 323539 | 1180444189 | K994375 | HORIZON LIGHT | FRN | 2000-03-08 |
| 17590 | 1385190241 | K994375 | HORIZON LIGHT | FRN | 2000-03-08 |
| 323539 | 1177748999 | K991879 | SPRING-WOUND EPIDURAL CATHETER | BSO | 1999-10-28 |
| 27946 | 1177748999 | K991879 | SPRING-WOUND EPIDURAL CATHETER | BSO | 1999-10-28 |
| 27950 | 1550036066 | K991653 | INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM | FPA | 1999-06-24 |
| 323539 | 1550036066 | K991653 | INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM | FPA | 1999-06-24 |
| 27950 | 1381479829 | K983794 | CHEMO MINI SPIKE PLUS | LHI | 1999-03-23 |
| 27946 | 1381479829 | K983794 | CHEMO MINI SPIKE PLUS | LHI | 1999-03-23 |
| 323539 | 1381479829 | K983794 | CHEMO MINI SPIKE PLUS | LHI | 1999-03-23 |
| 27946 | 1988063942 | K973322 | DIAPACT CRRT | KDI | 1998-11-10 |
| 27946 | 1050927481 | K972678 | MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS | FRN | 1997-10-07 |
| 323539 | 1331305913 | K971233 | SOFT TIP EPIDURAL CATHETER KIT | CAZ | 1997-10-17 |
| 323539 | 1410369884 | K970287 | LUMBAR PUNCTURE KIT | FMJ | 1997-04-07 |
| 27946 | 1410369884 | K970287 | LUMBAR PUNCTURE KIT | FMJ | 1997-04-07 |
| 27946 | 1055401411 | K964352 | TORQUE DEVICE | DQX | 1997-01-28 |
| 27946 | 1076189028 | K963440 | DIALOG DIALYSIS MACHINE | KDI | 1998-06-26 |
| 323539 | 1076189028 | K963440 | DIALOG DIALYSIS MACHINE | KDI | 1998-06-26 |
| 323539 | 1644974086 | K962696 | PERIFIX PEDIATRIC EPIDURAL KIT | CAZ | 1997-04-03 |
| 27946 | 1652904157 | K961147 | CLOSED FLUID COLLECTION SYSTEM | GBX | 1996-05-31 |
| 323539 | 1652904157 | K961147 | CLOSED FLUID COLLECTION SYSTEM | GBX | 1996-05-31 |
| 27946 | 1822672465 | K960674 | CONTRAST INJECTION LINES | DXT | 1996-09-19 |
| 323539 | 1822672465 | K960674 | CONTRAST INJECTION LINES | DXT | 1996-09-19 |
| 323539 | 2024054909 | K955585 | V2 INJECTION SITE | FPA | 1996-05-15 |
| 27946 | 2024054909 | K955585 | V2 INJECTION SITE | FPA | 1996-05-15 |
| 27946 | 1617280318 | K955179 | CONTRAST MEDIA SET | IZI | 1997-03-12 |
| 323539 | 1617280318 | K955179 | CONTRAST MEDIA SET | IZI | 1997-03-12 |
| 323539 | 1735178447 | K954123 | LOW PROFILE SAFSITE Y-SITE | FPA | 1995-11-21 |
| 27946 | 1735178447 | K954123 | LOW PROFILE SAFSITE Y-SITE | FPA | 1995-11-21 |
| 27950 | 1782497238 | K952810 | DOSI-FLOW, MODELS 20 & 30 | FPA | 1995-09-08 |
| 27946 | 1995996641 | K952631 | BRAUN HEMODIALYSIS BLOOD CIRCUITS | FJK | 1996-04-30 |
| 323539 | 1995996641 | K952631 | BRAUN HEMODIALYSIS BLOOD CIRCUITS | FJK | 1996-04-30 |
| 323539 | 1654356339 | K943770 | LOW VOLUME MULTIPORT | FPA | 1995-04-10 |
| 27946 | 1654356339 | K943770 | LOW VOLUME MULTIPORT | FPA | 1995-04-10 |
| 27946 | 1591390809 | K943181 | DISPENSING PIN WITH ONE-WAY VALVE | LHI | 1994-09-29 |
| 323539 | 1591390809 | K943181 | DISPENSING PIN WITH ONE-WAY VALVE | LHI | 1994-09-29 |
| 323539 | 1344947180 | K942988 | FILTERED EXTENSION SETS | FPA | 1995-07-14 |
| 27946 | 1344947180 | K942988 | FILTERED EXTENSION SETS | FPA | 1995-07-14 |
| 27946 | 1299145307 | K942391 | BRAUN MANIFOLD | DTL | 1995-06-21 |
| 27950 | 1032784921 | K941589 | SYRINGE FILTER DEVICES | FMF | 1994-09-06 |
| 323539 | 1032784921 | K941589 | SYRINGE FILTER DEVICES | FMF | 1994-09-06 |
| 323539 | 1503004029 | K932400 | ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY | BSP | 1993-12-13 |
| 27946 | 1503004029 | K932400 | ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY | BSP | 1993-12-13 |
| 27946 | 1781949044 | K931377 | SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT | FPA | 1994-03-07 |
| 323539 | 1781949044 | K931377 | SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT | FPA | 1994-03-07 |
| 323539 | 1139091498 | K925401 | IV FLUID TRANSFER PIN | LHI | 1993-03-03 |
| 27946 | 1139091498 | K925401 | IV FLUID TRANSFER PIN | LHI | 1993-03-03 |
| 323539 | 1107030394 | K922637 | HORIZON PUMP Y-TYPE BLOOD SET | FPA | 1993-06-04 |
| 27946 | 1107030394 | K922637 | HORIZON PUMP Y-TYPE BLOOD SET | FPA | 1993-06-04 |
| 27946 | 1461918154 | K921860 | MODIFICATION TO IV SPIKE | FPA | 1992-07-30 |
| 323539 | 1461918154 | K921860 | MODIFICATION TO IV SPIKE | FPA | 1992-07-30 |
| 27946 | 1338169650 | K915421 | GUIDEWIRE INTRODUCER SET | DYB | 1992-02-27 |
| 323539 | 1338169650 | K915421 | GUIDEWIRE INTRODUCER SET | DYB | 1992-02-27 |
| 27946 | 1972283386 | K913661 | MODIFIED VOLUMETRIC INFUSION PUMP | FRN | 1991-12-18 |
| 323539 | 1972283386 | K913661 | MODIFIED VOLUMETRIC INFUSION PUMP | FRN | 1991-12-18 |
| 323539 | 1155815642 | K904518 | VOLUMETRIC INFUSION PUMP | FRN | 1990-10-17 |
| 27946 | 1155815642 | K904518 | VOLUMETRIC INFUSION PUMP | FRN | 1990-10-17 |
| 27946 | 1128822499 | K903809 | PROTECTED NEEDLE WITH OR WITHOUT IV SET | FPA | 1990-10-03 |
| 323539 | 1128822499 | K903809 | PROTECTED NEEDLE WITH OR WITHOUT IV SET | FPA | 1990-10-03 |
| 27946 | 1274350698 | K902409 | BECTON DICKINSON 360 INFUSER (TM) SYSTEM | FRN | 1990-07-19 |
| 323539 | 1274350698 | K902409 | BECTON DICKINSON 360 INFUSER (TM) SYSTEM | FRN | 1990-07-19 |
| 323539 | 1934654556 | K900865 | ADD-A-VIAL II BINARY CONNECTOR | LHI | 1990-07-11 |
| 27946 | 1934654556 | K900865 | ADD-A-VIAL II BINARY CONNECTOR | LHI | 1990-07-11 |
| 323539 | 1728501480 | K895580 | Y-ADAPTER W/THOUY BORST | DYB | 1990-04-30 |
| 27946 | 1728501480 | K895580 | Y-ADAPTER W/THOUY BORST | DYB | 1990-04-30 |
| 323539 | 1648400442 | K895109 | SECONDARY IV SET WITH PROTECTED NEEDLE | FPA | 1989-09-27 |
| 27946 | 1648400442 | K895109 | SECONDARY IV SET WITH PROTECTED NEEDLE | FPA | 1989-09-27 |
| 27946 | 1501469905 | K894446 | ANGEION HEMOSTASIS VALVE INTRODUCER | DYB | 1989-11-30 |
| 323539 | 1501469905 | K894446 | ANGEION HEMOSTASIS VALVE INTRODUCER | DYB | 1989-11-30 |
| 323539 | 1027906936 | K884183 | BURRON TEFLON-COATED GUIDEWIRE | DQX | 1989-08-03 |
| 27946 | 1027906936 | K884183 | BURRON TEFLON-COATED GUIDEWIRE | DQX | 1989-08-03 |
| 27950 | 2012348778 | K875196 | DISPOSABLE CORONARY CONTROL SYRINGE 12CC | DXT | 1988-02-11 |
| 27946 | 1744744491 | K871153 | CATHETER INTRODUCER | DYB | 1987-06-24 |
| 323539 | 1744744491 | K871153 | CATHETER INTRODUCER | DYB | 1987-06-24 |
| 27950 | 1799975683 | K860126 | STIMUPLEX, NERVE STIMULATOR | BXN | 1986-02-28 |
| 323539 | 1799975683 | K860126 | STIMUPLEX, NERVE STIMULATOR | BXN | 1986-02-28 |
| 323539 | 1412746649 | K853014 | MCGHAN TISSUE EXPANDER FILL KIT | LCJ | 1985-09-18 |
| 27946 | 1412746649 | K853014 | MCGHAN TISSUE EXPANDER FILL KIT | LCJ | 1985-09-18 |
| 27950 | 1554310844 | K851058 | DOSI FLOW | LDR | 1985-04-29 |
| 323539 | 1473523356 | K844719 | 360 INFUSER | FRN | 1985-01-28 |
| 27946 | 1473523356 | K844719 | 360 INFUSER | FRN | 1985-01-28 |
| 27946 | 2039516873 | K841639 | NOVA BALLOON THERMODILUTION CATH. | DYG | 1984-08-12 |
| 323539 | 2039516873 | K841639 | NOVA BALLOON THERMODILUTION CATH. | DYG | 1984-08-12 |
| 323539 | 1535828721 | K840388 | PAB IV CONTAINER | KPE | 1984-03-06 |
| 27946 | 1535828721 | K840388 | PAB IV CONTAINER | KPE | 1984-03-06 |
| 27946 | 1106584795 | K840287 | BRACHIAL PLEXUS ANESTHESIA TRAY | CAZ | 1984-02-23 |
| 323539 | 1106584795 | K840287 | BRACHIAL PLEXUS ANESTHESIA TRAY | CAZ | 1984-02-23 |
| 27946 | 1865627798 | K840212 | CONCENTRATED PLATELET ADMIN. SET | FPA | 1984-03-06 |
| 323539 | 1865627798 | K840212 | CONCENTRATED PLATELET ADMIN. SET | FPA | 1984-03-06 |
| 27946 | 1971477606 | K840179 | CONTINUOUS EPIDURAL ANESTHES. TRAY | CAZ | 1984-02-24 |
| 323539 | 1971477606 | K840179 | CONTINUOUS EPIDURAL ANESTHES. TRAY | CAZ | 1984-02-24 |
| 27946 | 1305368617 | K822806 | BALLOON WEDGE PRESSURE, ANGIOGRAPHIC | DYG | 1982-11-01 |
| 323539 | 1305368617 | K822806 | BALLOON WEDGE PRESSURE, ANGIOGRAPHIC | DYG | 1982-11-01 |
| 27946 | 1278095072 | K820454 | THE RED CAP | FMF | 1982-03-08 |
| 323539 | 1278095072 | K820454 | THE RED CAP | FMF | 1982-03-08 |
| 27946 | 1936700375 | K820453 | THE INT-STOPPER | FPA | 1982-03-08 |
| 323539 | 1936700375 | K820453 | THE INT-STOPPER | FPA | 1982-03-08 |
| 27950 | 1338339833 | K820047 | SPINOCAN SPINAL NEEDLE | BSP | 1982-01-25 |
| 323539 | 1338339833 | K820047 | SPINOCAN SPINAL NEEDLE | BSP | 1982-01-25 |
| 323539 | 1806225102 | K813186 | PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO | CAZ | 1981-12-03 |
| 27946 | 2029993828 | K813092 | ACCUPRO I.V. ADMINISTRATION SET | FPA | 1981-12-31 |
| 323539 | 2029993828 | K813092 | ACCUPRO I.V. ADMINISTRATION SET | FPA | 1981-12-31 |
| 323539 | 1963111012 | K810460 | BURRON PERCUTANEOUS INDUCER SET | DQY | 1981-03-11 |
| 27946 | 1963111012 | K810460 | BURRON PERCUTANEOUS INDUCER SET | DQY | 1981-03-11 |
| 27946 | 1175287391 | K801311 | BURRON MULTI-AD SYRINGE CAP | FMF | 1980-06-17 |
| 323539 | 1175287391 | K801311 | BURRON MULTI-AD SYRINGE CAP | FMF | 1980-06-17 |
| 323539 | 1749100232 | K801108 | DOUBLE ENDED VENTED TRANSFER DEVICE | FMI | 1980-05-30 |
| 27946 | 1749100232 | K801108 | DOUBLE ENDED VENTED TRANSFER DEVICE | FMI | 1980-05-30 |
| 27946 | 1100663452 | K801107 | DOUBLE ENDED FILTERED TRANSFER NEEDLE | FMI | 1980-05-30 |
| 323539 | 1100663452 | K801107 | DOUBLE ENDED FILTERED TRANSFER NEEDLE | FMI | 1980-05-30 |
| 27946 | 1461978515 | K800437 | SYRINGE TIP CONNECTOR | KYX | 1980-03-12 |
| 323539 | 1461978515 | K800437 | SYRINGE TIP CONNECTOR | KYX | 1980-03-12 |
| 323539 | 1753853675 | K792227 | MULTI-AD FLUID DISPENSING SYSTEM | KYX | 1979-12-20 |
| 27946 | 1753853675 | K792227 | MULTI-AD FLUID DISPENSING SYSTEM | KYX | 1979-12-20 |
| 323539 | 1177415011 | K790062 | IV ADMINISTRATION SET WITH BACKCHECK | FPA | 1979-04-10 |
| 27946 | 1177415011 | K790062 | IV ADMINISTRATION SET WITH BACKCHECK | FPA | 1979-04-10 |
| 323539 | 1098121324 | K781744 | IV SET WITH GRADUATED CHAMBER | FPA | 1978-12-07 |
| 27946 | 1098121324 | K781744 | IV SET WITH GRADUATED CHAMBER | FPA | 1978-12-07 |
| 27946 | 1837093299 | K780551 | I.V. ADMINISTRATION SET WITH MINI-SPIKE | FPA | 1978-04-19 |
| 323539 | 1837093299 | K780551 | I.V. ADMINISTRATION SET WITH MINI-SPIKE | FPA | 1978-04-19 |
| 323539 | 1237015794 | K760392 | SYRINGES | FMF | 1976-11-02 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FPA | 66 | 2025-07-24 |
| FRN | 28 | 2018-06-12 |
| LHI | 19 | 2020-12-09 |
| FMF | 13 | 2020-03-05 |
| CAZ | 13 | 2012-01-24 |
| DYB | 11 | 2003-07-15 |
| FOZ | 10 | 2026-05-15 |
| FMI | 10 | 2018-06-11 |
| KDI | 9 | 2017-08-11 |
| BSP | 8 | 2020-05-27 |
| KPO | 8 | 2011-04-25 |
| KPE | 8 | 2008-03-12 |
| ONB | 7 | 2025-08-05 |
| FRO | 7 | 2017-05-23 |
| BSO | 6 | 2023-09-15 |
| FMG | 6 | 2022-09-15 |
| BXN | 5 | 2007-03-22 |
| FIP | 4 | 2023-08-16 |
| MRZ | 4 | 2020-03-12 |
| FJK | 4 | 2008-07-18 |
| DYG | 4 | 1984-08-12 |
| KYX | 4 | 1980-03-12 |
| DQX | 3 | 1997-01-28 |
| DXT | 3 | 1996-09-19 |
| LJH | 2 | 2026-09-10 |
| DTK | 2 | 2024-07-31 |
| GBM | 2 | 2018-11-05 |
| PTI | 2 | 2017-11-03 |
| GCB | 2 | 2015-11-12 |
| MEA | 2 | 2009-11-04 |
| MEB | 2 | 2008-07-15 |
| FKQ | 2 | 2006-06-09 |
| FMJ | 2 | 1997-04-07 |
| IZI | 2 | 1997-03-12 |
| GBX | 2 | 1996-05-31 |
| LCJ | 2 | 1985-09-18 |
| DQY | 2 | 1981-03-11 |
| KGZ | 2 | 1976-11-02 |
| JCY | 2 | 1976-11-02 |
| DQO | 2 | 1976-11-02 |
Levetiracetam
Levetiracetam
Dextrose
Sodium Chloride
ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE
POTASSIUM CHLORIDE
Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate
Water
Sodium Chloride
Sodium Chloride, Potassium Chloride, and Calcium Chloride
Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride
Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride
Acetic Acid
Cefazolin Sodium
Cefazolin Sodium
Cefazolin Sodium
CEFUROXIME AND DEXTROSE
CEFUROXIME AND DEXTROSE
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFTRIAXONE
CEFTRIAXONE
Meropenem and Sodium Chloride
Meropenem and Sodium Chloride
CEFEPIME HYDROCHLORIDE
CEFEPIME HYDROCHLORIDE
Heparin Sodium in Sodium Chloride
Piperacillin and Tazobactam and Sodium Chloride
Piperacillin and Tazobactam and Sodium Chloride
Piperacillin and Tazobactam and Sodium Chloride
Heparin Sodium in Sodium Chloride
Acetaminophen
Acetaminophen
Acetaminophen
magnesium sulfate heptahydrate
magnesium sulfate heptahydrate
magnesium sulfate heptahydrate
magnesium sulfate heptahydrate
Soybean Oil
LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. BRAUN MEDICAL INC.
B. Braun Medical Inc.
B. Braun Medical Inc.
B. Braun Medical Inc.
2026-09-27
2026-09-19
2026-08-17
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2016-09-23
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2016-09-23
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