Accessories, Blood Circuit, Hemodialysis

FDA product code KOC · 179 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5820
Review panel: GU
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1976-08-30 – 2025-05-15

KOC 2025-05-15

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU

Applicant NIKKISO CO., LTD.

K number K242479

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KOC 2025-05-15

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)

Applicant NIKKISO CO., LTD.

K number K242176

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KOC 2023-07-28

Blood Tubing Lines for Hemodialysis AV06C-E

Applicant NIKKISO CO., LTD.

K number K231589

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KOC 2023-06-16

Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series

Applicant NIKKISO CO., LTD.

K number K230514

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KOC 2020-09-18

CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K201207

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KOC 2017-12-14

CAREline Airless Hemodialysis Blood Tubing Sets

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K172238

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KOC 2016-04-15

CRIT-LINE III Blood Chamber II

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K160749

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KOC 2012-11-09

CRIT-LINE CLIP (CLIC)

Applicant Fresenius Medical Care-North America

K number K121599

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KOC 2009-03-30

NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P

Applicant NIKKISO CO., LTD.

K number K082719

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KOC 2009-03-12

HEMOBAND, MODELS HB-NS AND HB-NSXL

Applicant Innovations For Access, Inc.

K number K081740

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KOC 2008-12-19

PRISMAFLO II

Applicant Stihler Electronic GmbH

K number K082758

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KOC 2008-07-07

LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT

Applicant Nxstage Medical, Inc.

K number K081043

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KOC 2007-10-18

PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R

Applicant Barkey GmbH & Co. KG

K number K071909

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KOC 2003-07-11

VASC-ALERT

Applicant Vasc-Alert, LLC

K number K030456

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KOC 2002-10-30

\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR

Applicant Fresenius Medical Care

K number K022536

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KOC 2002-07-24

PRISMAFLO

Applicant Stihler Electronic GmbH

K number K020103

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KOC 2001-05-16

MODIFICATION TO MALE TO MALE LUER ADAPTER

Applicant Molded Products, Inc.

K number K003712

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KOC 2001-04-27

FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9

Applicant Fresenius Medical Care North America

K number K010268

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KOC 2000-11-22

TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV

Applicant Transonic Systems, Inc.

K number K002816

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KOC 2000-10-25

ACCESS ALERT GAUGE

Applicant Medisystems Corp.

K number K002372

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KOC 2000-03-20

REVERSO

Applicant Medisystems Corp.

K number K994306

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KOC 1999-01-08

JMS DIALYZER PRIMING SET

Applicant Jms Co., Ltd.

K number K983707

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KOC 1997-11-26

NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS

Applicant Nipro Medical Corp.

K number K972206

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KOC 1997-08-18

MEDISYSTEMS DIALYSIS PRIMING SETS

Applicant Medisystems Corp.

K number K971860

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KOC 1997-03-04

NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS

Applicant Nissho Corp.

K number K954676

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KOC 1997-01-30

CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS

Applicant Robert R. Stevens

K number K964041

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KOC 1996-02-16

ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS

Applicant Baxter Healthcare Corp

K number K955277

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KOC 1996-01-11

DIALYSIS ADMINISTRATION KITS

Applicant B.Braun Medical, Inc.

K number K952572

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KOC 1995-04-05

KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA

Applicant KARL STORZ Endoscopy-America, Inc.

K number K950282

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KOC 1995-03-13

DUAL LUMEN CATHETER (DLC) TRAY

Applicant Neostar Medical Technologies, Inc.

K number K941851

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KOC 1995-02-16

DIAL MEDICAL KIT

Applicant Regulatory & Marketing Services, Inc.

K number K941543

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KOC 1995-01-30

PRISM MEDICAL CUSTOM DIALYSIS KIT

Applicant Medical Device Support Services

K number K941803

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KOC 1995-01-19

CRIT-LINE BLOOD CHAMBER WITH E-BEAM

Applicant In-Line Diagnostics Corp.

K number K935958

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KOC 1994-10-07

SILICONE CATHETER REPAIR KITS

Applicant Akcess Medical Products, Inc.

K number K926374

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KOC 1994-09-30

CENTRYSYSTEM 3 WITH CHARTS/BP OPTION

Applicant C.G.H. Medical, Inc.

K number K925522

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KOC 1994-03-30

CD HOME DIALYSERVICE HEMODIALYSIS TRAY

Applicant Cd Medical, Inc.

K number K925654

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KOC 1994-03-15

BARD UROTRACK II MONITORING

Applicant C.R. Bard, Inc.

K number K924436

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KOC 1993-06-09

RS-1000

Applicant Cp Medical

K number K911230

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KOC 1993-01-28

DIGI -FLOW

Applicant D and D Technology, Inc.

K number K920671

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KOC 1992-07-27

HEMO-BAND

Applicant Innovations IN Access, Inc.

K number K920614

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KOC 1992-03-31

BARD(R) UROTACK(R) 210 MONITORING SYSTEM

Applicant C.R. Bard, Inc.

K number K912374

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KOC 1992-03-30

DRAIN/PRIMING/RECIRCULATION BAG

Applicant Haemotronic, Inc.

K number K913361

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KOC 1991-10-30

EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT

Applicant Baxter Healthcare Corp

K number K911315

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KOC 1991-09-27

MINNILERT(R) PRESSURE MONITOR

Applicant Minntech Corp.

K number K913483

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KOC 1991-05-28

MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG

Applicant Baxter Healthcare Corp

K number K911106

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KOC 1991-04-29

INTRODUCER NEEDLES

Applicant Akcess Medical Products, Inc.

K number K910641

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KOC 1991-04-16

Y ADAPTOR

Applicant Akcess Medical Products, Inc.

K number K910321

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KOC 1991-03-07

BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD

Applicant Gambro-Hospal, Inc.

K number K902588

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KOC 1990-04-20

HEMODIALYSIS BLOOD LINES

Applicant Gainor Medical Europe, Ltd.

K number K900306

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KOC 1990-02-12

MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.

Applicant National Medical Care, Medical Products Div., Inc.

K number K895244

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KOC 1990-02-09

JMS DIALYZER PRIMING SET

Applicant Jms Co., Ltd.

K number K895882

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KOC 1989-12-27

DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095

Applicant Baxter Healthcare Corp

K number K896006

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KOC 1989-09-22

NATIONAL MEDICAL CARE VENOUS LINE 03-9548

Applicant National Medical Care, Medical Products Div., Inc.

K number K894637

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KOC 1986-06-26

FAST FORMALERT

Applicant Organon Teknika Corp.

K number K853555

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KOC 1985-06-12

BSM 21 BLOOD SAFETY MODULE

Applicant Hospal Medical Corp.

K number K852135

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KOC 1985-06-12

BSM 22 BLOOD SAFETY MODULE

Applicant Hospal Medical Corp.

K number K852134

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KOC 1985-01-18

SARTORIUS MINISART SM 16596HY

Applicant Sartorius Filters, Inc.

K number K844504

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KOC 1985-01-03

MODIFIED C-DAK

Applicant Cd Medical, Inc.

K number K844185

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KOC 1984-11-16

ASN MONITOR SINGLE NEEDLE MONITOR

Applicant Organon Teknika Corp.

K number K843531

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KOC 1984-10-18

HOLLOW FIBER DIALYZER

Applicant Travenol Laboratories, S.A.

K number K843632

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KOC 1984-09-12

CAPILLARY FLOW DIALYZERS

Applicant Travenol Laboratories, S.A.

K number K840937

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KOC 1984-08-16

HOLLOW FIBER DIALYZERS

Applicant Travenol Laboratories, S.A.

K number K840845

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KOC 1984-07-13

ERIKA NEGATIVE PRESS. ARTERIAL BLOOD

Applicant Erika, Inc.

K number K842436

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KOC 1984-06-22

FILTRYZER HOLLOW FIBER ARTIF. KIDNEY

Applicant Erika, Inc.

K number K831176

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KOC 1984-06-22

FILTRYZER HOLLOW FIBER ARTIF. KIDNEY

Applicant Erika, Inc.

K number K831175

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KOC 1984-06-22

FILTRYZER HOLLOW FIBER ARTIFICIAL KID-

Applicant Erika, Inc.

K number K831174

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KOC 1984-06-22

TORAY INDUSTRIES FILTRYZER HOLLOW FIBER

Applicant Erika, Inc.

K number K831173

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KOC 1984-05-22

MAKS CENTRAL DELIVERY SYS-11-200 ETC

Applicant Erika, Inc.

K number K840859

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KOC 1984-05-02

DIALYSIS ADMIN. SET - I.V.

Applicant Cp Medical

K number K840654

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KOC 1984-04-20

DIALYSIS TRAY

Applicant Medcare Products

K number K841124

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KOC 1984-03-22

BSM 2000 DIALYSIS MACHINE

Applicant Organon Teknika Corp.

K number K840062

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KOC 1984-02-04

EXP* 700 PARALLEL PLATE DIALYZER

Applicant Extracorporeal Medical Specialities, Inc.

K number K840146

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KOC 1984-02-04

EXP* 500 PARALLEL PLATE DIALYZER

Applicant Extracorporeal Medical Specialities, Inc.

K number K840057

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KOC 1984-02-04

BLOOD TUBING

Applicant Renal Systems, Inc.

K number K834596

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KOC 1984-01-03

NEGATIVE PRESSURE VENOUS BLOOD LINE

Applicant Erika, Inc.

K number K833906

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KOC 1984-01-03

NEGATIVE PRESSURE ARTERIAL BLOOD

Applicant Erika, Inc.

K number K833905

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KOC 1984-01-03

BICARBOLYTE HEMO-DIAL

Applicant Edlaw Pharmaceuticals, Inc.

K number K833896

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KOC 1983-12-27

DUAL LUMEN NEEDLE

Applicant Quinton, Inc.

K number K833308

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KOC 1983-12-14

ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF

Applicant Erika, Inc.

K number K833252

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KOC 1983-12-08

CLIRANS MODEL TAF 15 HOLLOW FIBER

Applicant Terumo Medical Corp.

K number K833503

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KOC 1983-12-08

BLOOD SAFETY MODULE BSM2

Applicant Hospal Medical Corp.

K number K833440

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KOC 1983-11-28

D-LYTE

Applicant Dialysis Products, Inc.

K number K833653

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KOC 1983-11-28

MODIFICATION IN MEMBRANE HOUSING CONFI

Applicant Ries Biologicals

K number K832925

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KOC 1983-11-15

ASAHI HOLLOW FIBER KIDNEYS, EXCEL

Applicant Asahi Medical Co., Ltd.

K number K833150

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KOC 1983-10-14

LUNDIA 10-2-L PARALLEL PLATE HEMODIALY

Applicant Gambro, Inc.

K number K832894

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KOC 1983-10-14

NEPHROSS PRESTO

Applicant Organon Teknika Corp.

K number K832666

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KOC 1983-10-14

TOP DISPOS. INFUSION SET/HEMODIALY

Applicant Top Surgical Manufacturers Co.

K number K832623

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KOC 1983-09-29

SINGLE PATIENT SYS. II MODEL DM-450

Applicant Extracorporeal Medical Specialities, Inc.

K number K832053

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KOC 1983-09-26

TISSUE FORCEPS

Applicant Medcare Products

K number K831663

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KOC 1983-08-26

CLIRANS TAF06 HOLLOW FIBER DIALYZER

Applicant Terumo Medical Corp.

K number K832252

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KOC 1983-08-12

BLOOD TUBING SET

Applicant Lee Medical Intl., Inc.

K number K832103

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KOC 1983-07-07

ARTIFICIAL KIDNEY BLOOD CIRCUIT

Applicant Eiken Kizai Co., Ltd.

K number K831770

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KOC 1983-06-30

HAEMOLYTE SOLUTION

Applicant Dialysis Clinic, Inc.

K number K831409

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KOC 1983-06-24

GF-180-L HOLLOW FIBER HEMODIALYSIS

Applicant Gambro, Inc.

K number K831606

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KOC 1983-06-03

CLIRANS TAF 120 HOLLOW FIBER DIALYZ. &

Applicant Terumo Medical Corp.

K number K831482

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KOC 1983-06-03

CDS 2001 ARTIFICIAL KIDNEY

Applicant Elmar Medical Systems, Ltd.

K number K831376

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KOC 1983-06-02

EXTRASENSR ULTRAFILTRATION MONITOR

Applicant Extracorporeal Medical Specialities, Inc.

K number K831433

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KOC 1983-05-27

LUNDIA 10-3-L PARALLEL FLOW DIALYZER

Applicant Gambro, Inc.

K number K831338

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KOC 1983-04-06

LUNDIA 10-2-N PARALLEL FLOW DIALYZER

Applicant Gambro, Inc.

K number K830905

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KOC 1983-03-29

C-DAK ARTIFICIAL KIDNEY

Applicant Cordis Corp.

K number K830729

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