Bayer Healthcare L L C

FDA Filings

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

Bayer Healthcare L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1910953
FEI Number1910953
NameBAYER HEALTHCARE LLC
Owner & OperatorBAYER HEALTHCARE LLC, CONSUMER CARE DIVISION
Contact Address100 Bayer Boulevard PO Box 915
Whippany NJ 07981 US
Official Correspondent
  • Yake Yu
  • x-862-4042477-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address12707 SHAWNEE MISSION PKWY
Shawnee Mission, KS 66216 US
Establishment TypeRepack or Relabel Medical Device



Registration Number2243252
FEI Number2243252
NameBayer HealthCare, LLC
Owner & OperatorBayer Pharma, AG
Contact Address800 Dwight Way
Berkeley CA 94710 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address36 Columbia Rd
Morristown, NJ 07960 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Unifirst First Aid Corporation
Otc Medication2024-06-12
Bayer HealthCare LLC
Otc Medication2024-05-31
Bayer HealthCare LLC.
Otc Medication2024-05-24
Bayer Healthcare LLC, Patheon Softgels Inc.
Otc Medication2024-05-10
Sanofi-Aventis U.S. LLC, Bayer Healthcare LLC, Curia New York, Inc., Bausch Health Companies Inc.
Prescription Medication2024-05-10
Bayer Healthcare LLC
Otc Medication2024-05-09
Bayer Healthcare LLC.
Otc Medication2024-01-23
Bayer HealthCare LLC.
Otc Medication2024-01-23
Bayer HealthCare LLC.
Otc Medication2024-01-23
Unifirst First Aid Corporation, Bayer Healthcare LLC
Otc Medication2024-01-17
Unifirst First Aid Corporation
Otc Medication2024-01-17
Bayer Healthcare LLC
Otc Medication2024-01-10
Bayer HealthCare LLC
Otc Medication2023-12-14
Bayer HealthCare LLC., Bayer Healthcare LLC
Otc Medication2023-12-12
Lil' Drug Store Products, Inc.
Otc Medication2023-12-07
Bayer Healthcare LLC, Bayer de Mexico, S.A. de C.V.
Otc Medication2023-12-06
Bayer HealthCare LLC., Bayer Healthcare LLC
Otc Medication2023-12-05
Bayer HealthCare LLC.
Otc Medication2023-12-05
Bayer HealthCare LLC.
Otc Medication2023-12-05
Bayer HealthCare LLC
Other Medication2023-12-01
Bayer HealthCare LLC
Otc Medication2023-12-01
Bayer HealthCare LLC
Otc Medication2023-12-01
Bayer HealthCare LLC
Otc Medication2023-12-01
Bayer HealthCare LLC
Otc Medication2023-12-01
Bayer Healthcare LLC, Patheon Softgels Inc.
Otc Medication2023-12-01
Bayer HealthCare LLC
Other Medication2023-12-01
Bayer HealthCare LLC., Bayer HealthCare LLC Consumer Care
Otc Medication2023-12-01
Bayer HealthCare LLC.
Otc Medication2023-12-01
Bayer HealthCare LLC.
Otc Medication2023-12-01
Bayer HealthCare LLC.
Otc Medication2023-12-01
Bayer HealthCare LLC.
Otc Medication2023-12-01
Bayer HealthCare LLC.
Otc Medication2023-12-01
Bayer HealthCare LLC
Otc Medication2023-12-01
Bayer HealthCare LLC., Bayer HealthCare LLC Consumer Care
Otc Medication2023-12-01
Bayer HealthCare LLC., Bayer HealthCare LLC Consumer Care
Otc Medication2023-12-01
Bayer HealthCare LLC
Other Medication2023-12-01
Bayer HealthCare LLC.
Otc Medication2023-11-18
Bayer HealthCare LLC
Otc Medication2023-11-16
Bayer HealthCare LLC
Otc Medication2023-11-16
JC World Bell Wholesale Co., Inc., Bayer HealthCare LLC
Otc Medication2023-11-06
Bayer HealthCare LLC., Bayer Healthcare LLC
Otc Medication2023-10-20
Bayer HealthCare LLC.
Otc Medication2023-10-17
Bayer HealthCare LLC
Otc Medication2023-10-12
Bayer HealthCare LLC.
Otc Medication2023-09-19
Bayer HealthCare LLC
Otc Medication2023-09-15
Bayer HealthCare LLC
Otc Medication2023-09-15
Bayer HealthCare LLC
Otc Medication2023-09-15
Bayer HealthCare LLC.
Otc Medication2023-09-15
Bayer HealthCare LLC.
Otc Medication2023-09-15
Bayer HealthCare LLC
Otc Medication2023-09-10
Bayer HealthCare LLC.
Otc Medication2023-08-19
Lil' Drug Store Products, Inc.
Otc Medication2023-07-20
Bayer HealthCare LLC
Otc Medication2023-07-07
Bayer HealthCare LLC
Otc Medication2023-07-07
Bayer HealthCare LLC
Otc Medication2023-07-07
Bayer HealthCare LLC.
Otc Medication2023-07-07
Bayer Healthcare LLC, Bayer de Mexico, S.A. de C.V.
Otc Medication2023-05-24
Bayer HealthCare LLC.
Otc Medication2023-04-27
Bayer HealthCare LLC.
Otc Medication2023-04-19
Bayer HealthCare LLC
Otc Medication2023-02-28
Bayer HealthCare LLC
Otc Medication2023-02-28
Bayer HealthCare LLC.
Otc Medication2023-02-14
Lil' Drug Store Products, Inc.
Otc Medication2023-01-17
Bayer HealthCare LLC
Otc Medication2023-01-11
Bayer HealthCare LLC
Otc Medication2023-01-11
Bayer HealthCare LLC
Otc Medication2022-12-17
Bayer HealthCare LLC.
Otc Medication2022-12-13
Bayer HealthCare LLC
Other Medication2022-12-08
Bayer HealthCare LLC.
Otc Medication2022-12-08
Bayer HealthCare LLC
Otc Medication2022-12-06
Bayer HealthCare LLC
Otc Medication2022-12-03
Bayer HealthCare LLC
Other Medication2022-12-03
Bayer HealthCare LLC
Otc Medication2022-12-02
Bayer HealthCare LLC
Otc Medication2022-12-02
Bayer HealthCare LLC
Other Medication2022-12-02
Bayer HealthCare LLC.
Otc Medication2022-11-22
Bayer HealthCare LLC.
Otc Medication2022-11-18
Bayer HealthCare LLC.
Otc Medication2022-11-11
Bayer HealthCare LLC.
Otc Medication2022-11-11
Bayer HealthCare LLC.
Otc Medication2022-11-11
Bayer HealthCare LLC.
Otc Medication2022-11-10
Bayer HealthCare LLC
Animal Medication2022-11-02
Bayer HealthCare LLC
Animal Medication2022-11-02
Bayer HealthCare LLC.
Otc Medication2022-11-01
Bayer HealthCare LLC.
Otc Medication2022-11-01
Bayer HealthCare LLC
Otc Medication2022-10-27
Bayer HealthCare LLC
Otc Medication2022-10-21
Bayer HealthCare LLC.
Otc Medication2022-10-21
Lil' Drug Store Products, Inc.
Otc Medication2022-10-20
Bayer HealthCare LLC
Otc Medication2022-10-18
Bayer HealthCare LLC
Otc Medication2022-10-18
Bayer HealthCare LLC
Otc Medication2022-10-18
Bayer HealthCare LLC.
Otc Medication2022-10-18
Bayer HealthCare LLC., Bayer HealthCare LLC Consumer Care
Otc Medication2022-10-18
Bayer HealthCare LLC
Otc Medication2022-10-15
Bayer HealthCare LLC
Otc Medication2022-10-15
Bayer HealthCare LLC
Otc Medication2022-10-15
Bayer HealthCare LLC
Otc Medication2022-10-15
Bayer HealthCare LLC
Otc Medication2022-10-15
Bayer HealthCare LLC.
Otc Medication2022-10-15
BAYER HEALTHCARE LLC
2021-06-22 21:25:07
Bayer HealthCare LLC
Aleve Headache Pain2021-06-01
Bayer HealthCare LLC
Aleve Arthritis Pain Gel2021-06-01
Bayer HealthCare LLC
AleveX2021-04-01
BAYER HEALTHCARE LLC
Dr. Scholl's 2020-10-01
Bayer Healthcare LLC
Essure 2020-04-08
Bayer Healthcare LLC
Essure 2020-04-08
BAYER HEALTHCARE LLC
Dr. Scholl's 2019-11-04
BAYER HEALTHCARE LLC
Aleve 2019-10-23
BAYER HEALTHCARE LLC
Aleve 2019-10-23
BAYER HEALTHCARE LLC
Aleve 2019-10-23
Bayer HealthCare LLC
Jivi2018-08-30
Bayer HealthCare LLC
Jivi2018-08-30
Bayer HealthCare LLC
Jivi2018-08-30
Bayer HealthCare LLC
Jivi2018-08-30
Bayer Healthcare LLC
POWER PULSE 1048342018-08-09
BAYER HEALTHCARE LLC
Dr. Scholl's 2018-07-20
BAYER HEALTHCARE LLC
Dr. Scholl's 2018-07-20
Bayer Healthcare LLC
Essure 2018-07-06
Bayer Healthcare LLC
JETWIRE 0115252018-03-29
Bayer Healthcare LLC
JETSTREAM XC 1122662018-03-29
Bayer Healthcare LLC
JETSTREAM XC 1122642018-03-29
Bayer Healthcare LLC
JETSTREAM SC 1122622018-03-29
Bayer Healthcare LLC
JETSTREAM SC 1122602018-03-29
Bayer Healthcare LLC
JETSTREAM 0505992018-03-29
Bayer Healthcare LLC
DISTAFLEX 1113042018-03-29
Bayer Healthcare LLC
SOLENT DISTA 1113032018-03-29
Bayer Healthcare LLC
FETCH 2 1094002018-03-29
Bayer Healthcare LLC
SOLENT OMNI 1096812018-03-29
Bayer Healthcare LLC
SOLENT PROXI 1096762018-03-29
Bayer Healthcare LLC
ANGIOJET 1056502018-03-29
Bayer Healthcare LLC
XMI 1050412018-03-29
Bayer Healthcare LLC
SPIROFLEX 1065532018-03-29
Bayer Healthcare LLC
SPIROFLEX VG 1066082018-03-29
Bayer Healthcare LLC
XVG 1050422018-03-29
Bayer Healthcare LLC
AVX 1050392018-03-29
Bayer HealthCare LLC
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)2018-03-07
Bayer HealthCare LLC
2017-07-01
Bayer HealthCare LLC
2017-01-07
Bayer HealthCare LLC
2017-01-01
Bayer HealthCare LLC
2017-01-01
Bayer HealthCare LLC
RID Lice Elimination Essentials2016-09-28
Bayer HealthCare LLC
Afrin No-Drip Allergy Sinus2016-08-30
Bayer HealthCare LLC
RID Lice Treatment Complete Kit2016-05-09
Bayer HealthCare LLC
Kovaltry2016-03-17
Bayer HealthCare LLC
Kovaltry2016-03-17
Bayer HealthCare LLC
Kovaltry2016-03-17
Bayer HealthCare LLC
Kovaltry2016-03-17
Bayer HealthCare LLC
Kovaltry2016-03-17
BAYER HEALTHCARE, LLC
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)2015-12-22
Bayer HealthCare LLC
Midol PM2014-12-15
Bayer HealthCare LLC
Midol Complete Gelcaps2014-12-15
BAYER HEALTHCARE LLC
CONTOUR NEXT EZ BLOOD GLUCOSE METER2014-06-23
Bayer HealthCare LLC
Tinactin Antifungal2014-02-28
Bayer HealthCare, LLC [Bayer Pharma, AG]
Essure2014-01-10
Bayer HealthCare LLC
Kogenate FS2013-06-26
Bayer HealthCare LLC
Kogenate FS2013-06-26
Bayer HealthCare LLC
Kogenate FS2013-06-26
Bayer HealthCare LLC
Kogenate FS2013-06-26
Bayer HealthCare LLC
Kogenate FS2013-06-26
Bayer HealthCare LLC
Coppertone Oil Free Faces SPF 50 Plus2013-02-01
BAYER HEALTHCARE LLC
CONTOUR NEXT BLOOD GLUCOSE METER2012-07-26
Bayer HealthCare LLC
Bayer Headache Relief2012-06-01
BAYER HEALTHCARE, LLC
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)2012-03-28
Bayer HealthCare LLC
Zegerid OTC2010-04-01
BAYER HEALTHCARE LLC
DIDGET WORLD REPORTS2010-03-12
Bayer HealthCare LLC
A And D Original2009-12-25
BAYER HEALTHCARE, LLC
DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 70802009-12-04
BAYER HEALTHCARE, LLC
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC2009-05-14
BAYER HEALTHCARE, LLC
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE2008-10-08
BAYER HEALTHCARE, LLC
ADVIA CHEMISTRY TOTAL BILIRUBIN_22007-12-07
BAYER HEALTHCARE, LLC
CLINITEK ADVANTUS, MODEL 14202006-12-28
Bayer HealthCare LLC
Claritin Reditabs2006-12-12
BAYER HEALTHCARE, LLC
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM2006-11-22
BAYER HEALTHCARE, LLC
ADVIA IMS CPSA CONTROL2006-07-06
BAYER HEALTHCARE, LLC
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM2005-12-30
BAYER HEALTHCARE, LLC
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM2005-12-14
BAYER HEALTHCARE, LLC
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM2005-12-07
BAYER HEALTHCARE, LLC
ADVIA IMS GLUCOSE ASSAY2005-10-11
BAYER HEALTHCARE LLC
ADVIA CHEMISTRY MICROALBUMIN CONTROLS2005-10-03
BAYER HEALTHCARE, LLC
ADVIA IMS LITHIUM ASSAY2005-06-15
BAYER HEALTHCARE, LLC
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY2005-06-13
BAYER HEALTHCARE, LLC
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS2005-04-22
BAYER HEALTHCARE, LLC
ASCENSIA ELITE DIABETES CARE SYSTEM2004-12-22
BAYER HEALTHCARE, LLC
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM2004-12-22
BAYER HEALTHCARE, LLC
ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS2004-12-22
BAYER HEALTHCARE, LLC
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM2004-09-17
BAYER HEALTHCARE, LLC
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER2004-07-02
BAYER HEALTHCARE, LLC
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS2004-06-14
BAYER HEALTHCARE, LLC
CLINITEST HCG PREGNANCY TEST2003-12-23
BAYER HEALTHCARE, LLC
BAYER CLINITEK STATUS ANALYZER2003-12-19
BAYER HEALTHCARE, LLC
BAYER RAPIDLAB 1200 SYSTEM2003-12-17
BAYER HEALTHCARE, LLC
BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER2003-09-09
BAYER HEALTHCARE, LLC
ADVIA 60 HEMATOLOGY ANALYZER2003-09-08
BAYER HEALTHCARE, LLC
TOX AMMONIA CALIBRATOR2003-08-06
Bayer HealthCare LLC
Midol Teen2003-07-01
BAYER HEALTHCARE, LLC
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL2003-06-25
BAYER HEALTHCARE, LLC
BAYER ADVIA CENTAUR CA 19-9 ASSAY2003-06-24
BAYER HEALTHCARE, LLC
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY2003-06-23
Bayer HealthCare LLC
A And D First Aid2003-06-04
BAYER HEALTHCARE, LLC
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR2003-04-10
BAYER HEALTHCARE, LLC
SETPOINT CHEMISTRY CALIBRATOR2003-01-31
BAYER HEALTHCARE, LLC
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 32003-01-24
Bayer Healthcare LLC
Claritin Reditabs2002-11-27
Bayer Healthcare LLC
Claritin Reditabs2002-11-27
Bayer HealthCare LLC
Lotrimin2002-02-01
Bayer HealthCare LLC
Afrin No Drip Extra Moisturizing2000-08-31
Bayer HealthCare LLC
Afrin No Drip Severe Congestion2000-08-31
Bayer Healthcare LLC
Coppertone Kids SPF 501999-05-21
Bayer HealthCare LLC
Coppertone Kids Sunscreen SPF 701999-05-21
Bayer HealthCare LLC
Coppertone Sensitive Skin SPF 501999-05-21
Bayer HealthCare LLC
Bain De Soleil Orange Gelee SPF 41999-05-21
Bayer HealthCare LLC
Coppertone Oil Free Faces Sunscreen SPF 301999-05-21
Bayer HealthCare LLC
Coppertone Sport SPF 151999-05-21
BAYER HEALTHCARE, LLC
CIBA CORNING ACS PSA IMMUNOASSAY1998-12-08
BAYER HEALTHCARE, LLC
CIBA CORNING ACS PSA IMMUNOASSAY1998-12-08
BAYER HEALTHCARE, LLC
CIBA CORNING ACS PSA IMMUNOASSAY1995-12-13
Bayer HealthCare LLC
Mexsana Medicated1993-09-23
Bayer HealthCare LLC
Tinactin1993-09-23
Bayer HealthCare LLC
Tinactin1993-09-23
Bayer HealthCare LLC
Coppertone WaterBABIES Sunscreen SPF 501993-05-12
Bayer HealthCare LLC
Claritin1993-04-12
Bayer HealthCare LLC
DuoFilm Wart Remover1990-08-14
Bayer HealthCare LLC
Dr. Scholls Corn Removers1990-08-14
BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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BAYER HEALTHCARE LLC
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Similar & Related FDA Registered Companies

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
201810196859Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyPLASTIC INJECTION TUBING1248 CTN
201810196859Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyPLASTIC INJECTION TUBING1248 CTN
2018101844082Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaKP18 KVP KIEL44 PCS
2018101829768Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyALUMINIUM FOIL AS PER INVOICE NO: 768679 HS:76072050002 PKG
2018101844083Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaADVANTAGE II LARGE CAT 4X0 8ML HS 38089190900 SERESTO COLLAR FOR LARGE DOGS (SC KIEL) HS 3808919090043 PCS
2018101840966Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia6 X 0 8 CC ADVANTAGE MULTI 18 CAT HS 38089190900 ADVANTAGE MULTI 110 DOG 6 X 5 0 ML HS 3808919090048 PCS
2018101844080Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaADVANTAGE II SMALL CAT 4X0 4ML HS 38089190900 ADVANTAGE II SMALL DOG 4X0 4ML HS 3808919090039 PCS
2018101844081Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaSERESTO COLLAR FOR LARGE DOGS (SC KIEL) HS 3808919090044 PCS
2018101839267Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaSERESTO COLLAR FOR LARGE DOGS HS 38089190900 K9 ADVANTIX II SMALL DOG 4X0 4ML HS 3808919090040 PCS

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