Fresenius Kabi Usa L L C

FDA Filings

This page includes the latest FDA filings for Fresenius Kabi Usa L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Fresenius Kabi Usa L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1321116
FEI Number3001833549
NameFresenius Kabi USA, LLC
Owner & OperatorFresenius Kabi USA, LLC
Contact Address3 Corporate Drive
Lake Zurich IL 60047 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3159 STALEY RD.
GRAND ISLAND, NY 14072 US
Establishment TypeManufacture Medical Device



Registration Number3002733956
FEI Number3002733956
NameFresenius Kabi USA, LLC
Owner & OperatorFresenius Kabi USA, LLC
Contact Address3 Corporate Drive
Lake Zurich IL 60047 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3 CORPORATE DR STE 300
Lake Zurich, IL 60047 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Fresenius Kabi USA, LLC
Prescription Medication2024-12-20
Fresenius Kabi USA, LLC
Prescription Medication2024-12-13
Fresenius Kabi USA, LLC, Merck Serono S.A.
Prescription Medication2024-12-09
FRESENIUS KABI USA, LLC, Fresenius Kabi USA, LLC
Prescription Medication2024-11-26
Fresenius Kabi USA, LLC
Prescription Medication2024-10-31
Fresenius Kabi USA, LLC
Prescription Medication2024-10-30
Fresenius Kabi USA, LLC
Prescription Medication2024-10-23
Fresenius Kabi USA, LLC, Istituto Biochimico Italiano Giovanni Lorenzini
Prescription Medication2024-10-23
Fresenius Kabi USA, LLC, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site)
Prescription Medication2024-10-22
Fresenius Kabi USA, LLC
Prescription Medication2024-10-22
Fresenius Kabi USA, LLC
Prescription Medication2024-10-19
Fresenius Kabi USA, LLC
Prescription Medication2024-10-19
Fresenius Kabi USA, LLC, Shilpa Medicare Limited
Prescription Medication2024-10-18
Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH
Prescription Medication2024-10-10
Fresenius Kabi USA, LLC
Prescription Medication2024-09-15
Fresenius Kabi USA, LLC
Prescription Medication2024-09-05
Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS
Prescription Medication2024-08-29
Fresenius Kabi USA, LLC
Prescription Medication2024-08-26
Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH
Prescription Medication2024-08-23
Fresenius Kabi USA, LLC, Fresenius Kabi Austria, HP Halden Pharma AS
Prescription Medication2024-08-14
Fresenius Kabi USA, LLC
Prescription Medication2024-08-02
Fresenius Kabi USA, LLC, Caplin Steriles Limited
Prescription Medication2024-07-27
Phlow Corporation, Fresenius Kabi USA, LLC
Prescription Medication2024-07-04
Fresenius Kabi USA, LLC
Prescription Medication2024-06-19
Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS
Prescription Medication2024-05-24
Fresenius Kabi USA, LLC, HP Halden Pharma AS, Fresenius Kabi Deutschland GmbH
Prescription Medication2024-05-24
Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS
Prescription Medication2024-05-24
Fresenius Kabi USA, LLC
Prescription Medication2024-05-18
Fresenius Kabi USA, LLC, Fresenius Kabi Austria, HP Halden Pharma AS
Prescription Medication2024-05-17
Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS
Prescription Medication2024-05-02
Fresenius Kabi USA, LLC, HP Halden Pharma AS
Prescription Medication2024-04-27
Fresenius Kabi USA, LLC
Prescription Medication2024-04-17
Fresenius Kabi USA, LLC
Prescription Medication2024-04-04
Fresenius Kabi USA, LLC
Prescription Medication2024-04-02
Fresenius Kabi USA, LLC, Gland Pharma Limited
Prescription Medication2024-03-14
Phlow Corporation, Fresenius Kabi USA, LLC
Prescription Medication2024-03-12
Fresenius Kabi USA, LLC, Fresenius Kabi Austria, HP Halden Pharma AS
Prescription Medication2024-02-29
Phlow Corporation, Fresenius Kabi USA, LLC
Prescription Medication2024-02-24
Phlow Corporation, Fresenius Kabi USA, LLC
Prescription Medication2024-02-24
Fresenius Kabi USA, LLC
Prescription Medication2024-02-23
Fresenius Kabi USA, LLC, Gland Pharma Limited
Prescription Medication2024-02-15
Fresenius Kabi USA, LLC
Prescription Medication2024-02-02
Fresenius Kabi USA, LLC, Bracco Diagnostics Inc., Fresenius Kabi USA, LLC
Prescription Medication2024-01-31
Fresenius Kabi USA, LLC, Caplin Steriles Limited
Prescription Medication2024-01-27
Fresenius Kabi USA, LLC
Prescription Medication2024-01-27
Fresenius Kabi USA, LLC
Prescription Medication2024-01-24
GRIFOLS USA, LLC, Grifols Biologicals LLC, LABORATORIOS GRIFOLS SA, Fresenius Kabi USA LLC
Other Medication2024-01-23
Fresenius Kabi USA, LLC
Prescription Medication2024-01-19
Fresenius Kabi USA, LLC
Prescription Medication2024-01-17
Fresenius Kabi USA, LLC, Fresenius Medical Care North America
Prescription Medication2024-01-12
HUB Pharmaceuticals LLC, Hospira, Inc., Fresenius Kabi USA, LLC
Prescription Medication2024-01-10
Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS
Prescription Medication2024-01-05
Fresenius Kabi USA, LLC
Prescription Medication2023-12-31
Fresenius Kabi USA, LLC
Prescription Medication2023-12-19
Fresenius Kabi USA, LLC
Prescription Medication2023-12-08
Fresenius Kabi USA, LLC
Prescription Medication2023-12-08
Fresenius Kabi USA, LLC, Fresenius Kabi Austria, HP Halden Pharma AS
Prescription Medication2023-12-02
Fresenius Kabi USA, LLC, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site)
Prescription Medication2023-11-17
Bracco Diagnostics Inc., Jubilant HollisterStier LLC, Fresenius Kabi USA, LLC, Bachem AG
Prescription Medication2023-10-20
Fresenius Kabi USA, LLC, Fresenius Medical Care North America
Prescription Medication2023-10-17
GRIFOLS USA, LLC, Grifols Biologicals LLC, LABORATORIOS GRIFOLS SA
Other Medication2023-10-09
Fresenius Kabi USA, LLC
Prescription Medication2023-10-07
Fresenius Kabi USA, LLC, GLAND PHARMA LIMITED, Gland Pharma Limited
Prescription Medication2023-10-07
GRIFOLS USA, LLC, Grifols Biologicals LLC, LABORATORIOS GRIFOLS SA, Fresenius Kabi USA LLC
Other Medication2023-09-27
Fresenius Kabi USA, LLC, Gland Pharma Limited
Prescription Medication2023-09-12
Fresenius Kabi USA, LLC, Fresenius Kabi, USA LLC
Prescription Medication2023-09-10
GRIFOLS USA, LLC, Grifols Biologicals LLC, LABORATORIOS GRIFOLS SA, Fresenius Kabi USA LLC
Other Medication2023-08-30
GRIFOLS USA, LLC, Grifols Biologicals LLC, LABORATORIOS GRIFOLS SA, Fresenius Kabi USA LLC
Other Medication2023-08-15
FRESENIUS KABI USA, LLC
Prescription Medication2023-08-03
Fresenius Kabi USA, LLC
Prescription Medication2023-07-27
Fresenius Kabi USA, LLC, ACS Dobfar SPA, ACS Dobfar SpA
Prescription Medication2023-07-21
Fresenius Kabi USA, LLC
Prescription Medication2023-07-20
Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS
Prescription Medication2023-07-11
Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH, Merck Serono S.p.A (MS-Bari)
Prescription Medication2023-07-07
Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH, Merck Serono S.p.A (MS-Bari)
Prescription Medication2023-07-01
Fresenius Kabi USA, LLC
Prescription Medication2023-06-21
Fresenius Kabi USA, LLC
Prescription Medication2023-06-07
Fresenius Kabi USA, LLC
Prescription Medication2023-06-03
Fresenius Kabi USA, LLC, GLAND PHARMA LIMITED, Gland Pharma Limited
Prescription Medication2023-05-10
Fresenius Kabi USA, LLC, Fresenius Medical Care North America
Prescription Medication2023-04-20
GRIFOLS USA, LLC, Grifols Biologicals LLC, LABORATORIOS GRIFOLS SA
Other Medication2023-04-15
Fresenius Kabi USA, LLC, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site), Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)
Prescription Medication2023-04-14
Fresenius Kabi USA, LLC, Bracco Diagnostics Inc., Fresenius Kabi USA, LLC
Prescription Medication2023-04-01
Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS
Prescription Medication2023-03-25
Fresenius Kabi USA, LLC
Prescription Medication2023-03-16
Fresenius Kabi USA, LLC, Fresenius Medical Care North America
Prescription Medication2023-03-08
Fresenius Kabi USA, LLC
Prescription Medication2023-03-01
Fresenius Kabi USA, LLC, GLAND PHARMA LIMITED
Prescription Medication2023-02-04
Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS
Prescription Medication2023-01-18
Fresenius Kabi USA, LLC
Prescription Medication2023-01-15
Fresenius Kabi USA, LLC
Prescription Medication2023-01-10
Fresenius Kabi USA, LLC, Sanofi-Aventis U.S. LLC, sanofi-aventis Deutschland GmbH, Genzyme Corporation, Sanofi Winthrop Industrie, VLG CHEM, Aventis Pharma Manufacturing Pte. Ltd.
Prescription Medication2023-01-05
HUB Pharmaceuticals LLC, Hospira, Inc., Fresenius Kabi USA, LLC
Prescription Medication2022-12-17
Fresenius Kabi USA, LLC
Prescription Medication2022-12-17
Fresenius Kabi USA, LLC, HP Halden Pharma AS
Prescription Medication2022-12-13
Fresenius Kabi USA, LLC, Caplin Steriles Limited
Prescription Medication2022-12-08
Fresenius Kabi USA, LLC, GLAND PHARMA LIMITED, Gland Pharma Limited
Prescription Medication2022-12-08
Bracco Diagnostics Inc., Jubilant HollisterStier LLC, Fresenius Kabi USA, LLC, Bachem AG
Prescription Medication2022-12-08
Fresenius Kabi USA, LLC, Gland Pharma Limited
Prescription Medication2022-12-08
FRESENIUS KABI USA, LLC
Prescription Medication2022-11-15
Fresenius Kabi USA, LLC
Sodium Chloride2022-02-14
Fresenius Kabi USA, LLC
Sodium Chloride2021-04-28
Fresenius Kabi USA, LLC
Sodium Chloride2021-04-28
Fresenius Kabi USA LLC.
Automated Blood Cell Separators2019-06-06
Fresenius Kabi USA, LLC
LACTATED RINGERS2019-01-28
Fresenius Kabi USA LLC
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike And Luer Adapter2018-12-04
Fresenius Kabi USA, LLC
Neostigmine Methylsulfate2018-09-18
Fresenius Kabi USA, LLC
Dexamethasone Sodium Phosphate2018-07-06
Fresenius Kabi USA, LLC
Morphine Sulfate2018-04-10
Fresenius Kabi USA, LLC
Melphalan2017-12-22
Fresenius Kabi USA, LLC
Adenosine2017-11-27
Fresenius Kabi USA, LLC
SODIUM ACETATE2017-10-30
Fresenius Kabi USA LLC.
Automated Blood Cell Separators2017-10-10
Fresenius Kabi USA, LLC
Epirubicin Hydrochloride2017-07-31
Fresenius Kabi USA, LLC
Sodium Bicarbonate2017-07-28
Fresenius Kabi USA, LLC
Sodium Bicarbonate2017-07-28
Fresenius Kabi USA, LLC
Calcium Gluconate2017-06-15
Fresenius Kabi USA LLC.
Automated Blood Cell Separators2017-04-07
Fresenius Kabi USA, LLC
Dilaudid2016-12-16
Fresenius Kabi USA, LLC
Dilaudid2016-12-16
FRESENIUS KABI USA LLC
AMICUS Separator System, AMICUS Separator System; Refurbished2016-11-23
Fresenius Kabi USA, LLC
VANCOMYCIN HYDROCHLORIDE2016-08-17
Fresenius Kabi USA, LLC
Heparin Sodium2016-06-10
Fresenius Kabi USA LLC.
Automated Blood Cell Separators2016-04-20
Fresenius Kabi USA, LLC
Magnesium Sulfate2016-03-15
Fresenius Kabi USA, LLC
Magnesium Sulfate2016-03-15
Fresenius Kabi USA, LLC
Magnesium Sulfate In 5% Dextrose2016-03-07
Fresenius Kabi USA, LLC
ONDANSETRON2015-12-10
Fresenius Kabi USA, LLC
Glucagon2015-12-01
Fresenius Kabi USA, LLC
Glucagon2015-12-01
Fresenius Kabi USA, LLC
Ketorolac Tromethamine2015-11-02
Fresenius Kabi USA, LLC
Ketorolac Tromethamine2015-11-02
Fresenius Kabi USA, LLC
Ketorolac Tromethamine2015-11-02
Fresenius Kabi USA, LLC
Dexamethasone Sodium Phosphate2015-10-30
Fresenius Kabi USA LLC.
Automated Blood Cell Separators2015-08-28
Fresenius Kabi USA LLC.
Automated Blood Cell Separators2015-07-22
Fresenius Kabi USA, LLC
Glucagon2015-05-08
Fresenius Kabi USA, LLC
Enoxaparin Sodium2015-03-15
Fresenius Kabi USA, LLC
Cisatracurium2015-02-26
Fresenius Kabi USA, LLC
Neostigmine Methylsulfate2015-01-08
Fresenius Kabi USA, LLC
Neostigmine Methylsulfate2015-01-08
Fresenius Kabi USA, LLC
Midazolam2014-10-03
Fresenius Kabi USA, LLC
Midazolam2014-10-03
Fresenius Kabi USA, LLC
Midazolam2014-10-03
Fresenius Kabi USA, LLC
Rifampin2014-08-21
Fresenius Kabi USA, LLC
Morphine Sulfate2013-10-30
Fresenius Kabi USA, LLC
Morphine Sulfate2013-10-30
Fresenius Kabi USA, LLC
Morphine Sulfate2013-10-30
Fresenius Kabi USA, LLC
Morphine Sulfate2013-10-30
Fresenius Kabi USA, LLC
Morphine Sulfate2013-10-30
Fresenius Kabi USA, LLC
Metoclopramide2013-05-03
Fresenius Kabi USA, LLC
Diphenhydramine Hydrochloride2013-03-26
Fresenius Kabi USA, LLC
Acetylcysteine2012-09-01
Fresenius Kabi USA LLC.
Blood Bank Supplies2012-08-02
Fresenius Kabi USA, LLC
Tranexamic Acid2012-05-24
Fresenius Kabi USA, LLC
Imipenem And Cilastatin2012-01-03
Fresenius Kabi USA, LLC
Meropenem2011-10-26
Fresenius Kabi USA, LLC
GEMCITABINE2011-07-26
Fresenius Kabi USA, LLC
GEMCITABINE2011-07-26
Fresenius Kabi USA, LLC
Cefoxitin2011-07-06
Fresenius Kabi USA, LLC
Cefoxitin2011-07-06
Fresenius Kabi USA, LLC
Nafcillin2011-06-30
Fresenius Kabi USA, LLC
Levothyroxine Sodium2011-06-24
Fresenius Kabi USA, LLC
Ceftriaxone2011-06-20
Fresenius Kabi USA, LLC
Cefazolin2011-06-14
Fresenius Kabi USA, LLC
Piperacillin And Tazobactam2011-05-31
Fresenius Kabi USA, LLC
Naropin2011-05-31
Fresenius Kabi USA, LLC
GEMCITABINE2011-05-16
Fresenius Kabi USA, LLC
Nafcillin2011-04-27
Fresenius Kabi USA, LLC
Chorionic Gonadotropin2011-04-21
Fresenius Kabi USA, LLC
Heparin Lock Flush2011-01-13
Fresenius Kabi USA, LLC
Heparin Lock Flush2011-01-13
Fresenius Kabi USA, LLC
Fluphenazine Decanoate2010-12-15
Fresenius Kabi USA, LLC
Sensorcaine MPF2010-11-19
Fresenius Kabi USA, LLC
SENSORCAINE2010-11-19
Fresenius Kabi USA, LLC
Nesacaine2010-10-14
Fresenius Kabi USA, LLC
Cefepime2010-08-30
Fresenius Kabi USA, LLC
Xylocaine MPF2010-08-12
Fresenius Kabi USA, LLC
Xylocaine2010-08-12
Fresenius Kabi USA, LLC
Xylocaine2010-08-12
Fresenius Kabi USA, LLC
Heparin Sodium2010-06-18
Fresenius Kabi USA, LLC
Heparin Sodium2010-06-18
Fresenius Kabi USA, LLC
Carboplatin2009-12-11
Fresenius Kabi USA, LLC
Colistimethate2009-12-04
Fresenius Kabi USA, LLC
Ondansetron2009-11-18
Fresenius Kabi USA, LLC
Diprivan2009-11-13
Fresenius Kabi USA, LLC
Aztreonam2009-11-05
Fresenius Kabi USA, LLC
Piperacillin And Tazobactam2009-10-13
Fresenius Kabi USA, LLC
Heparin Sodium2009-08-12
Fresenius Kabi USA, LLC
Idarubicin Hydrochloride2009-08-11
Fresenius Kabi USA, LLC
Ampicillin And Sulbactam2006-11-27
Fresenius Kabi USA, LLC
Mitoxantrone2006-04-11
Fresenius Kabi USA, LLC
Octreotide2006-03-14
Fresenius Kabi USA, LLC
Tobramycin2005-11-23
Fresenius Kabi USA, LLC
Cladribine2004-12-01
Fresenius Kabi USA, LLC
Vancomycin Hydrochloride2004-11-30
Fresenius Kabi USA, LLC
Methylprednisolone Sodium Succinate2004-11-30
Fresenius Kabi USA, LLC
Ifosfamide2003-01-28
Fresenius Kabi USA, LLC
Propranolol2001-09-07
Fresenius Kabi USA, LLC
Etoposide2001-07-18
Fresenius Kabi USA, LLC
Pentam 3002001-01-16
Fresenius Kabi USA, LLC
Sodium Chloride2001-01-12
Fresenius Kabi USA, LLC
Chloramphenicol Sodium Succinate2001-01-12
Fresenius Kabi USA, LLC
Protamine Sulfate2000-10-18
Fresenius Kabi USA, LLC
Cyanocobalamin2000-10-18
Fresenius Kabi USA, LLC
Doxy 1002000-10-17
Fresenius Kabi USA, LLC
VANCOMYCIN HYDROCHLORIDE2000-09-20
Fresenius Kabi USA, LLC
Dexamethasone Sodium Phosphate2000-09-07
Fresenius Kabi USA, LLC
Cisplatin2000-09-05
Fresenius Kabi USA, LLC
VANCOMYCIN HYDROCHLORIDE2000-09-01
Fresenius Kabi USA, LLC
Thiamine2000-09-01
Fresenius Kabi USA, LLC
Oxytocin2000-08-10
Fresenius Kabi USA, LLC
Gentamicin2000-08-10
Fresenius Kabi USA, LLC
Potassium Phosphates2000-08-08
Fresenius Kabi USA, LLC
Magnesium Sulfate2000-08-08
Fresenius Kabi USA, LLC
Fluorouracil2000-07-12
Fresenius Kabi USA, LLC
Doxorubicin Hydrochloride2000-06-14
Fresenius Kabi USA, LLC
Mannitol2000-03-19
Fresenius Kabi USA, LLC
Haloperidol Decanoate2000-02-16
Fresenius Kabi USA, LLC
Methotrexate2000-01-22

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092663914Anvers,Belgium -> Baltimore, MarylandMACHINERY HS 8421.39 FREIGHT PREPAID .10 PCS
2020092550652Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaINSPECTION MACHINE HS CODE 9031.80.805 PCS
2020092550652Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaINSPECTION MACHINE HS CODE 9031.80.80 CTC CLARI SCHUYLER PHONE OFFICE 1 716 685-9585 PCS
2020092429889La Spezia,Italy -> New York/Newark Area, Newark, New JerseyEMPTY GLASS CONTAINERS4356 CTN
2020092434693La Spezia,Italy -> New York/Newark Area, Newark, New JerseyEMPTY GLASS CONTAINERS2880 CTN
2020092261337Anvers,Belgium -> Baltimore, MarylandMACHINERY 1999827 FILING LINE ISOLATOR LINE 7 WGT HS 8421.39 FREIGHT PREPAID12 PCS
2020092152794Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia. FFX FILLING LINE HS CODE 8422.30.0023 PCS
2020092152794Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia. TRANSPORT SYSTEM HS CODE 8428.90.90 CTC CLARI SCHUYLER PHONE OFFICE 1 716 685-95823 PCS
2020092152794Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia. FFX FILLING LINE HS CODE 8422.30.0023 PCS
2020092152794Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia. FFX FILLING LINE HS CODE 8422.30.0023 PCS
2020092152794Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia. FFX FILLING LINE HS CODE 8422.30.0023 PCS
2020092152794Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia. PRODUCT TRANSPORT HS CODE 8428.90.9023 PCS
2020092152794Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia. FFX FILLING LINE HS CODE 8422.30.0023 PCS
2020092152794Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia. FFX FILLING LINE HS CODE 8422.30.0023 PCS
2020092154896Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaINSPECTION MACHINE HS CODE 9031.80.80 CTC CLARI SCHUYLER PHONE OFFICE 1 716 685-9585 PCS
2020092154896Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaINSPECTION MACHINE HS CODE 9031.80.805 PCS
2020091947074La Spezia,Italy -> New York/Newark Area, Newark, New JerseyEMPTY GLASS CONTAINERS2880 CTN

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