BD E-Z Scrub 107
chlorhexidine gluconate
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1213809 | 1213809 | Becton, DIckinson and Company | 1 | N | 2026-01-01 | ROUTE 7 AND GRACE WAY CANAAN CT US 06018 |
| 1911916 | 1911916 | BECTON DICKINSON AND COMPANY | 1 | N | 2026-01-01 | 2153 12th Ave COLUMBUS NE US 68601 |
| 3008007472 | 3008007472 | Becton, Dickinson and Company | 1 | N | 2026-01-01 | 1022 CORPORATE PARK DRIVE Mebane NC US 27302 |
| 3015292643 | 3015292643 | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | 1 | Y | 2026-01-01 | 2600 Melksee Street San Diego CA US 92154 |
| 3027394506 | 3027394506 | Becton, Dickinson and Company, BD Biosciences | 1 | N | 2026-01-01 | 155 North McCarthy Boulevard Milpitas CA US 95035 |
| 3032916632 | 3032916632 | BECTON, DICKINSON AND COMPANY | 1 | Y | 2026-01-01 | 17200 Laguna Canyon Rd Irvine CA US 92618 |
| 2916837 | 2916837 | Becton, Dickinson and Company, BD Biosciences | 1 | N | 2020-04-25 | 2350 QUME DR. San Jose CA US 95131 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00382904453497 | BD BACTEC™ FXI Culture System Workflow Module - 445349 | +1(800)638-8663 | Technical_services@bd.com |
| 00382904453503 | BD BACTEC™ FXI Culture System Analyzer Module - 445350 | +1(800)638-8663 | Technical_services@bd.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 109028 | 1367663964 | P970018 | BD PREPSTAIN SYSTEM | MKQ | 1999-06-17 |
| 27564 | 2068919674 | K992734 | BECTON DICKINSON SYRINGE | MEG | 1999-10-01 |
| 339440 | 1624623896 | K983802 | LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB | MJN | 1999-07-30 |
| 78194 | 2028140746 | K981342 | ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY | GKZ | 1998-06-29 |
| 317894 | 2028140746 | K981342 | ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY | GKZ | 1998-06-29 |
| 27564 | 1459435978 | K980987 | BECTON DICKINSON SYRINGE | FMF | 1998-06-11 |
| 27593 | 1459435978 | K980987 | BECTON DICKINSON SYRINGE | FMF | 1998-06-11 |
| 78194 | 1106511780 | K980858 | MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION | GKZ | 1998-05-22 |
| 317894 | 1106511780 | K980858 | MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION | GKZ | 1998-05-22 |
| 27564 | 1121598424 | K980580 | BECTON DICKINSON SYRINGES | FMF | 1998-06-25 |
| 27564 | 2035939117 | K974363 | BECTON DICKINSON BLUNT PLASTIC CANNULA | FMI | 1998-06-03 |
| 27593 | 2035939117 | K974363 | BECTON DICKINSON BLUNT PLASTIC CANNULA | FMI | 1998-06-03 |
| 27564 | 1713792899 | K974006 | BECTON DICKINSON TWINPAK | FMI | 1998-01-22 |
| 27593 | 1713792899 | K974006 | BECTON DICKINSON TWINPAK | FMI | 1998-01-22 |
| 78194 | 1359494826 | K973483 | FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET | GKZ | 1998-02-17 |
| 317894 | 1359494826 | K973483 | FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET | GKZ | 1998-02-17 |
| 78194 | 1998688778 | K971205 | TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-12-01 |
| 317894 | 1998688778 | K971205 | TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-12-01 |
| 78194 | 1064288628 | K971110 | TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-11-25 |
| 317894 | 1064288628 | K971110 | TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-11-25 |
| 78194 | 1384647625 | K970836 | TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS | GKZ | 1997-08-26 |
| 317894 | 1384647625 | K970836 | TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS | GKZ | 1997-08-26 |
| 78194 | 1806840734 | K970742 | TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-10-22 |
| 317894 | 1806840734 | K970742 | TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-10-22 |
| 78194 | 1130378748 | K970326 | TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-11-21 |
| 317894 | 1130378748 | K970326 | TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-11-21 |
| 78194 | 1428533714 | K963963 | MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS | GKZ | 1996-12-12 |
| 317894 | 1428533714 | K963963 | MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS | GKZ | 1996-12-12 |
| 78194 | 1750196610 | K953302 | FACS LOADER SYSTEM | GKZ | 1995-11-20 |
| 317894 | 1750196610 | K953302 | FACS LOADER SYSTEM | GKZ | 1995-11-20 |
| 339440 | 1402540327 | K951566 | SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] | DYG | 1995-11-27 |
| 27564 | 1410905779 | K951254 | SAFETYGLIDE NEEDLE | FMI | 1995-10-07 |
| 27593 | 1410905779 | K951254 | SAFETYGLIDE NEEDLE | FMI | 1995-10-07 |
| 78194 | 1423731790 | K950057 | TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP | GKZ | 1995-08-22 |
| 317894 | 1423731790 | K950057 | TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP | GKZ | 1995-08-22 |
| 78194 | 2012398865 | K946055 | TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP | GKZ | 1996-02-20 |
| 27564 | 1326736560 | K944757 | PISTON SYRINGES | FMI | 1995-01-11 |
| 27593 | 1932408568 | K944320 | VENTED/NON-VENTED GEMINI ADMINISTRATION SET | FPA | 1995-02-14 |
| 339440 | 1849442333 | K942457 | GRAFT THROMBECTOMY INSTRUMENTS | MCW | 1995-02-07 |
| 27564 | 1305998968 | K941562 | 1ML LUER-LOK SYRINGE | FMF | 1994-05-26 |
| 339440 | 1230174822 | K940795 | SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER | DYG | 1994-05-24 |
| 27564 | 1026307884 | K940697 | BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK | FPA | 1994-08-30 |
| 27593 | 1026307884 | K940697 | BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK | FPA | 1994-08-30 |
| 339440 | 1276395751 | K934742 | SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT | DYG | 1994-01-24 |
| 78194 | 1550916376 | K933486 | FASCOUNT SYSTME | GKZ | 1994-09-09 |
| 317894 | 1550916376 | K933486 | FASCOUNT SYSTME | GKZ | 1994-09-09 |
| 27593 | 1697386161 | K931173 | PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH | FPA | 1994-04-15 |
| 339440 | 1802546451 | K926450 | EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH | DQE | 1993-02-22 |
| 339440 | 1301038450 | K925638 | PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 | DXO | 1993-10-18 |
| 339440 | 1760674244 | K924661 | SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER | KRA | 1993-04-08 |
| 78194 | 1492615083 | K924587 | SIMULTEST CD3/ANTI-HLA-DR | GKZ | 1993-08-05 |
| 317894 | 1492615083 | K924587 | SIMULTEST CD3/ANTI-HLA-DR | GKZ | 1993-08-05 |
| 339440 | 1113427413 | K924452 | SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER | DYG | 1993-10-29 |
| 27564 | 1509842408 | K924439 | BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA | FMI | 1993-02-12 |
| 27593 | 1509842408 | K924439 | BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA | FMI | 1993-02-12 |
| 27564 | 1954536149 | K924072 | BECTON DICKINSON SAFETY-LOK SYRINGE | FMF | 1992-12-17 |
| 78194 | 1867469915 | K923790 | FACSORT FLOW CYTOMETER | GKZ | 1993-09-01 |
| 27593 | 1007679150 | K920422 | B-D INTERLINK SYRINGE CANNULA | FMF | 1992-04-29 |
| 339440 | 2073667714 | K915726 | PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH | DQO | 1992-09-21 |
| 78194 | 1967909349 | K913192 | SIMULTEST(TM) IMK-LYMPHOCYTE | GKZ | 1992-02-06 |
| 317894 | 1967909349 | K913192 | SIMULTEST(TM) IMK-LYMPHOCYTE | GKZ | 1992-02-06 |
| 339440 | 1097746347 | K910204 | SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) | DQO | 1991-04-24 |
| 339440 | 1748949150 | K905707 | BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS | FGE | 1991-02-13 |
| 339440 | 1177215850 | K905458 | SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER | DQE | 1991-02-07 |
| 78194 | 1722322524 | K904390 | ANTI-HUMAN LEU-2A (CD8) PE | GKZ | 1990-12-17 |
| 317894 | 1722322524 | K904390 | ANTI-HUMAN LEU-2A (CD8) PE | GKZ | 1990-12-17 |
| 339440 | 2031753840 | K901736 | OXIMETRY PROBE CATHETERS | DQE | 1990-09-11 |
| 339440 | 1584598161 | K901625 | FOGARTY ARTERIAL EMBOLECTOMY II CATHETER | DXE | 1990-07-06 |
| 78194 | 1476606197 | K900802 | ANTI-HUMAN LEU-3A (CD4) FITC | GKZ | 1990-05-15 |
| 317894 | 1476606197 | K900802 | ANTI-HUMAN LEU-3A (CD4) FITC | GKZ | 1990-05-15 |
| 78194 | 1625036503 | K900078 | SIMULTEST IMK PLUS(TM) | GKZ | 1990-04-02 |
| 317894 | 1625036503 | K900078 | SIMULTEST IMK PLUS(TM) | GKZ | 1990-04-02 |
| 339440 | 1734450555 | K896819 | VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION | KRA | 1990-01-19 |
| 339440 | 1773021761 | K896466 | SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME | DYG | 1990-02-08 |
| 339440 | 1068978934 | K892410 | FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER | DXE | 1989-07-20 |
| 78194 | 1686548868 | K880636 | RETICCOUNT SOFTWARE | GKL | 1988-03-21 |
| 317894 | 1686548868 | K880636 | RETICCOUNT SOFTWARE | GKL | 1988-03-21 |
| 78194 | 1450633012 | K872166 | FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT | GKL | 1987-09-30 |
| 78194 | 1626927089 | K864893 | ANTI-CYTOKERATIN MONOCLONAL ANTIBODY | LYE | 1988-07-07 |
| 317894 | 1626927089 | K864893 | ANTI-CYTOKERATIN MONOCLONAL ANTIBODY | LYE | 1988-07-07 |
| 339440 | 1216484974 | K864330 | SHEAR FORCE GAUGE | DXE | 1987-01-06 |
| 78194 | 1502302874 | K851639 | ANTI-LEU-12 B CELL REAGENT | LJD | 1986-07-02 |
| 317894 | 1502302874 | K851639 | ANTI-LEU-12 B CELL REAGENT | LJD | 1986-07-02 |
| 78194 | 1677055159 | K842218 | ANTI-LEU-4 FITC LYSIN C BUFFER | LIZ | 1984-12-27 |
| 317894 | 1677055159 | K842218 | ANTI-LEU-4 FITC LYSIN C BUFFER | LIZ | 1984-12-27 |
| 339440 | 1904290553 | K832554 | FOGARTY 6MM SOFTJAW CLIP | DXC | 1983-09-29 |
| 339440 | 1468888625 | K822723 | SWAN-GANZ BIPOLAR PACING CATHETER | DYG | 1982-10-15 |
| 339440 | 1509749320 | K822350 | SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH | DYG | 1982-08-24 |
| 339440 | 1473786671 | K821416 | DISPOSABLE BLOOD PRESSURE TRANSDUCER | DRS | 1982-07-02 |
| 339440 | 1189017095 | K820222 | SWAN-GANZ VIP-CATHETER | DYG | 1982-02-12 |
| 339440 | 1894594523 | K813521 | TRANSLUMINAL BIPOLAR PACING PROBE | LDF | 1982-03-15 |
| 339440 | 1165348493 | K812563 | SWAN-GANZ & EDSLAB HEPARIN COATED CATH. | DYG | 1981-09-25 |
| 339440 | 1361762553 | K811411 | SWAN-GANZ HEPARIN COATED, ETC. CATHETER | KRB | 1981-06-12 |
| 339440 | 1703298987 | K811399 | EDSLAB CLOSED INJECTATE DELIVERY SYSTEM | KRB | 1981-06-09 |
| 339440 | 1990791780 | K810352 | SWAN-GANZ FLOW-DIRECTED THERMODILUTION | DYG | 1981-03-27 |
| 339440 | 1130553587 | K810162 | FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 | DXC | 1981-02-04 |
| 339440 | 1735338808 | K810124 | SWAN-GANZ VIP THERMODILUTION CATHETER | DYG | 1981-02-04 |
| 339440 | 1414520258 | K803058 | SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. | LDF | 1981-01-16 |
| 27564 | 1666781958 | K801343 | B-D FILTER NEEDLE | FPB | 1980-06-20 |
| 27593 | 1666781958 | K801343 | B-D FILTER NEEDLE | FPB | 1980-06-20 |
| 339440 | 1204896052 | K791183 | SWAN-GANZ FLOW-DIRECTED CATHETER | LDF | 1979-07-12 |
| 27593 | 1092483444 | K790582 | INTRAVASCULAR ADMINISTRATION SET | FPA | 1979-05-29 |
| 339440 | 1480140132 | K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | DXC | 2026-06-05 |
| 339440 | 1038748636 | K253186 | HemoSphere Nano Monitor (HSNANO1) | DQK | 2026-02-24 |
| 339440 | 1551645930 | K253034 | HemoSphere Stream Module | DQK | 2025-10-21 |
| 339440 | 1312740283 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | DQK | 2025-12-18 |
| 339440 | 1732095306 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) | DQK | 2025-07-23 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GKZ | 51 | 2009-07-31 |
| DYG | 19 | 2024-12-09 |
| FMI | 19 | 2002-07-19 |
| FMF | 18 | 2016-12-19 |
| DQK | 14 | 2026-02-24 |
| DXE | 9 | 2024-08-28 |
| DQE | 8 | 2018-02-20 |
| DXN | 6 | 2023-10-24 |
| DXO | 6 | 2022-12-22 |
| KRA | 6 | 2018-11-08 |
| FPA | 6 | 2001-06-19 |
| OYE | 5 | 2020-09-28 |
| MEG | 5 | 2001-06-13 |
| NGT | 4 | 2017-02-02 |
| LDF | 4 | 2015-10-15 |
| PER | 4 | 2013-08-02 |
| KNT | 4 | 2011-09-29 |
| DXC | 3 | 2026-06-05 |
| DRS | 3 | 2025-03-21 |
| MUD | 3 | 2023-11-17 |
| NZW | 3 | 2017-02-27 |
| MJN | 3 | 2015-11-23 |
| DXG | 3 | 2014-05-22 |
| KRB | 3 | 2010-12-07 |
| DQO | 3 | 2002-03-08 |
| GKL | 3 | 1988-03-21 |
| QEH | 2 | 2020-09-04 |
| PMG | 2 | 2015-12-17 |
| LKB | 2 | 2013-03-20 |
| LON | 2 | 2005-04-29 |
| SCL | 2 | 2003-09-09 |
| DYB | 2 | 2003-06-20 |
| LYE | 2 | 1988-07-07 |
| LJD | 2 | 1986-07-02 |
| LIZ | 2 | 1984-12-27 |
| FPB | 2 | 1980-06-20 |
| QMS | 1 | 2024-08-02 |
| QTI | 1 | 2022-07-16 |
| QBP | 1 | 2020-11-09 |
| PSQ | 1 | 2017-11-17 |
chlorhexidine gluconate
chloroxylenol
povidone-iodine
SODIUM CHLORIDE
SODIUM CHLORIDE
3% Sodium Chloride
SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE
Dextrose Monohydrate
Dextrose Monohydrate
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Water
SODIUM CHLORIDE
Dextrose Monohydrate
SODIUM CHLORIDE
Water
Isopropyl Alcohol
BECTON, DICKINSON AND COMPANY7 Loveton Circlesparks, MD 21152 PMA NumberP160037 Supplement NumberS013 Date Received11/21/2022 Decision Date12/07/2022 Product Code MAQ Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Ch...
BECTON, DICKINSON AND COMPANY7 Loveton Circlesparks, MD 21152 PMA NumberP160037 Supplement NumberS011 Date Received10/21/2022 Decision Date11/19/2022 Product Code MAQ Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Ch...
BECTON, DICKINSON AND COMPANY
BECTON, DICKINSON AND COMPANY
BECTON, DICKINSON AND COMPANY
BECTON, DICKINSON AND COMPANY
BECTON, DICKINSON AND COMPANY
BECTON, DICKINSON AND COMPANY
BECTON, DICKINSON AND COMPANY
BECTON, DICKINSON AND COMPANY
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company (Bard Access Systems, Inc.)
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson and Company
Becton, Dickinson And Company
Becton, Dickinson And Company
Becton, Dickinson And Company
Becton, Dickinson And Company
Becton, Dickinson And Company
Becton, Dickinson and Company
Becton Dickinson And Company
Becton Dickinson And Company
Becton, Dickinson And Company
Becton, Dickinson And Company
Becton, Dickinson And Company
Becton, Dickinson And Company
Becton, Dickinson And Company
2020-09-30
2020-09-30
2020-09-30
2024-06-07
2024-06-07
2020-09-30
2026-06-02
2026-06-02
2024-03-25
2023-09-02
2023-09-02
2024-06-06
2024-06-06
2024-06-06
2024-06-06
2024-06-06
2024-06-06
2023-09-02
2023-09-02
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2026-05-30
2016-09-19
2016-09-19
2017-03-20
2016-09-19