Set, Administration, Intravascular

FDA product code FPA · 1138 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5440
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-16 – 2026-09-11

FPA 2000-07-21

KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD

Applicant Kawasumi Laboratories America, Inc.

K number K001424

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FPA 2000-07-21

KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY

Applicant Kawasumi Laboratories America, Inc.

K number K001423

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FPA 2000-05-31

SURGEN VALVE

Applicant Tiva Medical

K number K990331

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FPA 2000-05-10

POSI-LINK

Applicant Icu Medical, Inc.

K number K000472

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FPA 2000-04-27

CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090

Applicant Sims Deltec, Inc.

K number K000942

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FPA 2000-04-20

PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E

Applicant Rd Medical Mfg., Inc.

K number K001102

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FPA 2000-03-03

VENUSA, LTD. EXTENSION SET WITH FILTER

Applicant Venusa , Ltd.

K number K994429

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FPA 2000-03-01

NAC Y-ADP

Applicant The Kipp Group

K number K000343

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FPA 2000-02-29

KIPPMED I.V. MANIFOLD

Applicant The Kipp Group

K number K000152

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FPA 2000-02-23

EXEL INJECTION PLUG WITH CAP

Applicant Exel Intl.

K number K992290

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FPA 2000-02-10

PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400

Applicant Rd Medical Mfg., Inc.

K number K000017

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FPA 2000-01-27

MILLENNIUM HUBER PLUS SAFETY INFUSION SET

Applicant Millennium Medical Distribution, Inc.

K number K993848

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FPA 2000-01-04

INTRAVASCULAR ADMINISTRATION SET

Applicant Custom Assemblies, Inc.

K number K993463

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FPA 1999-11-05

SHELLY PROTECTED AV FISTULA NEEDLE

Applicant Diasol, Inc.

K number K993187

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FPA 1999-11-05

DAISY PROTECTED SCALP VEIN SET

Applicant Diasol, Inc.

K number K992999

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FPA 1999-11-02

DECAP

Applicant The Kipp Group

K number K993147

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FPA 1999-10-27

IV ADMINISTRATION SET

Applicant New Alliance of Independent Medical Distributors,

K number K992266

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FPA 1999-10-14

ECOMED SCALP VEIN SET

Applicant Greiner Meditech, Inc.

K number K992145

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FPA 1999-09-15

NAC PRN NEEDLELESS ACCESS CONNECTOR

Applicant The Kipp Group

K number K992268

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FPA 1999-09-15

BOLUS ACCESSORY SET

Applicant I-Flow Corp.

K number K992072

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FPA 1999-09-03

SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321

Applicant Medtronic Minimed

K number K991979

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FPA 1999-09-02

SAGE CONTRAST MANAGEMENT SYSTEM

Applicant Sage Laboratories, Inc.

K number K991112

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FPA 1999-08-25

MED-RX EXTENSION SETS

Applicant Benlan, Inc.

K number K990777

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FPA 1999-08-23

PARSET, MODEL A10001E

Applicant Rd Medical Mfg., Inc.

K number K992104

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FPA 1999-08-20

COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET

Applicant Cook, Inc.

K number K991985

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FPA 1999-08-20

INTRAVASCULAR ADMINISTRATION SET

Applicant The Kipp Group

K number K991932

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FPA 1999-08-12

AB2 MED-FLO SOLUTION SET

Applicant Ab2 Medical Products, Llp

K number K984569

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FPA 1999-07-26

LUER ACCESS INJECTION SITE

Applicant Baxter Healthcare Corp

K number K984060

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FPA 1999-07-01

ANESFLOW-DUAL DRIP IV INFUSION SET

Applicant Innovative Design Assoc.

K number K990496

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FPA 1999-06-25

MAERSK MEDICAL CONTOUR INFUSION SET

Applicant Maersk Medical A/S

K number K991759

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FPA 1999-06-24

INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM

Applicant Rymed Technologies, Inc.

K number K991653

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FPA 1999-06-21

HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO

Applicant I-Flow Corp.

K number K991513

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FPA 1999-06-15

CADD ADMINISTRATION SET

Applicant Sims Deltec, Inc.

K number K991599

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FPA 1999-06-09

CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1

Applicant Sims Deltec, Inc.

K number K991301

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FPA 1999-06-09

CADD-TPN ADMINISTRATION SET, MODEL 21-7071

Applicant Sims Deltec, Inc.

K number K991255

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FPA 1999-05-14

FLEXNEEDLE PLUS

Applicant Act Medical, Inc.

K number K990693

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FPA 1999-03-29

TUTOPLUS IV ADMINISTRATION SET

Applicant Myco Medical Supplies, Inc.

K number K990388

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FPA 1999-03-01

TUTODROP 1 AND TUTODROP 2

Applicant Myco Medical Supplies, Inc.

K number K982098

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FPA 1999-02-24

FREE FLOW SAFETY DEVICE, MODEL MG 245052

Applicant Teva Medical, Ltd.

K number K990288

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FPA 1999-02-22

KVO CHECK VALVE ACCESSORY, MODEL EV-0001

Applicant I-Flow Corp.

K number K984441

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FPA 1999-02-19

BURETROL SOLUTION SETS

Applicant Baxter Healthcare Corp

K number K984381

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FPA 1999-02-12

CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER

Applicant Sims Deltec, Inc.

K number K990083

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FPA 1999-02-09

PARAGON BOLUS ACCESSORY SET

Applicant I-Flow Corp.

K number K984638

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FPA 1999-02-09

PARAGON INFUSION

Applicant I-Flow Corp.

K number K984146

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FPA 1999-02-09

PARAGON BASAL/BOLUS ADMINISTRATION SET

Applicant I-Flow Corp.

K number K984063

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FPA 1999-02-09

COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105

Applicant Valnet Medical Corp.

K number K983411

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FPA 1999-02-04

SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B

Applicant Msr, Inc.

K number K984561

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FPA 1999-01-20

MPS GRAVITY FLOW CONTROL SET

Applicant Critical Device Corp.

K number K983926

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FPA 1999-01-20

ROWE DUAL-CHECK VALVE

Applicant Cook, Inc.

K number K983217

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FPA 1998-12-16

I.V. EXTENSION SET OR I.V. ADMINISTRATION SET

Applicant Integra Biotechnical, LLC

K number K983073

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FPA 1998-09-04

COLLEAGUE PUMP SYRINGE ADAPTER SET

Applicant Baxter Healthcare Corp

K number K982672

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FPA 1998-08-24

MPS FIXED FLOW RATE SET

Applicant Medical Product Specialists

K number K982587

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FPA 1998-08-17

SOLUTION ADMINISTRATION SET

Applicant Baxter Healthcare Corp

K number K981792

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FPA 1998-07-28

HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y

Applicant Venusa , Ltd.

K number K981683

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FPA 1998-07-21

CONTRAST CONTROL DEVICE

Applicant Medex, Inc.

K number K982123

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FPA 1998-07-21

MPS HUBER NEEDLE EXTENSION SET

Applicant Medical Product Specialists

K number K982047

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FPA 1998-06-29

MANAN BLUNT NEEDLE

Applicant Manan Medical Products, Inc.

K number K981386

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FPA 1998-06-18

NFC NEEDLEFREE CONNECTOR MODEL 69900

Applicant Filtertek, Inc.

K number K981548

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FPA 1998-06-18

NFC NEEDLEFREE Y-SITE, MODEL 69970

Applicant Filtertek, Inc.

K number K981547

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FPA 1998-06-16

STABLE FLOW

Applicant Cmed

K number K981157

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FPA 1998-05-29

IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES

Applicant Venetec Intl., Inc.

K number K980994

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FPA 1998-05-28

IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES

Applicant Venetec Intl., Inc.

K number K980992

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FPA 1998-05-21

SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE

Applicant Baxter Healthcare Corp

K number K974571

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FPA 1998-04-27

EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE

Applicant Sims Deltec, Inc.

K number K980583

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FPA 1998-04-22

DUAL LUER LOCK CAP

Applicant Baxter Healthcare Corp

K number K981318

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FPA 1998-03-11

6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT

Applicant Catheter Innovations, Inc.

K number K980127

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FPA 1998-03-09

NP MEDICAL CAPLESS LUER ACTIVATED VALVE

Applicant Np Medical, Inc.

K number K973916

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FPA 1998-02-02

MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316

Applicant Medtronic Minimed

K number K974163

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FPA 1998-01-23

MCKINLEY OUTBOUND-2 SYSTEM

Applicant Mckinley, Inc.

K number K971844

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FPA 1998-01-09

SMARTVALVE

Applicant Icu Medical, Inc.

K number K974589

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FPA 1998-01-06

V3 VALVE

Applicant B.Braun Medical, Inc.

K number K974145

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FPA 1997-12-17

EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE

Applicant Sims Deltec, Inc.

K number K974013

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FPA 1997-12-17

PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY

Applicant Globe Ent., Inc.

K number K972854

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FPA 1997-12-17

PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET

Applicant Globe Ent., Inc.

K number K972839

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FPA 1997-12-16

EXEL I.V. ADMINISTRATION SET

Applicant Exel Intl.

K number K963659

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FPA 1997-11-17

POSITIVE PRESSURE CONNECTOR

Applicant Icu Medical, Inc.

K number K973167

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FPA 1997-10-02

AMSINO I.V. ADMINISTRATION SET

Applicant Amsino Intl., Inc.

K number K973107

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FPA 1997-10-02

MEDCORP FLOW I.V. REGULATOR EXTENSION SET

Applicant Medcorp Intl.

K number K971004

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FPA 1997-10-01

CORE RESISTANT HUBER INFUSION SETS

Applicant Icu Medical, Inc.

K number K972712

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FPA 1997-09-29

SA-EF MULTI-LUMEN EXTENSION SET

Applicant Vlv Associates, Inc.

K number K972957

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FPA 1997-09-18

PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS

Applicant Quality System Consulting

K number K972527

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FPA 1997-09-18

NIPRO DISPOSABLE SOLUTION INFUSION SET

Applicant Nipro Medical Corp.

K number K972493

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FPA 1997-09-08

DYE STOP AND SAVE - QUICKFILL

Applicant Shepherd Laboratories, Inc.

K number K971624

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FPA 1997-09-02

SMART SET

Applicant Top Spins, Inc.

K number K972663

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FPA 1997-08-26

MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET

Applicant P/L Biomedical

K number K972135

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FPA 1997-08-18

ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER

Applicant Biological & Environmental Control Laboratories

K number K971500

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FPA 1997-07-16

NEEDLE-FREE VALVED CONNECTOR AND CAP

Applicant Bmw Medical, Inc.

K number K964439

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FPA 1997-06-27

LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE

Applicant Abbott Mfg., Inc.

K number K971293

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FPA 1997-06-24

CLAVE CONNECTOR

Applicant Icu Medical, Inc.

K number K970855

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FPA 1997-06-24

VENTED I.V. SET

Applicant Jms Co., Ltd.

K number K965027

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FPA 1997-06-06

CONTINU-FLO SOLUTION SET

Applicant Baxter Healthcare Corp

K number K971701

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FPA 1997-06-05

GORE IRRIGATION SET

Applicant W. L. Gore & Associates, Inc.

K number K964067

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FPA 1997-06-04

TAMARYN I.V. FLOW REGULATOR EXTENSION SET

Applicant Tamaryn Medical Systems, Inc.

K number K971066

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FPA 1997-05-06

SAFE-CONNECT I.V. SET

Applicant Faulding Medical Device Co.

K number K970909

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FPA 1997-05-01

SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518

Applicant Faulding Medical Device Co.

K number K971266

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FPA 1997-04-22

SAFE-CONNECT I.V. EXTENSION SET

Applicant Faulding Medical Device Co.

K number K970524

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FPA 1997-04-21

SMARTSITE ACCESS PIN

Applicant Ivac Medical Systems

K number K970485

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FPA 1997-04-14

KIPP MED I.V. MANIFOLD

Applicant The Kipp Group

K number K970255

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FPA 1997-04-14

NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS

Applicant Critical Device Corp.

K number K964918

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FPA 1997-04-08

E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET

Applicant Becton Dickinson Vascular Access, Inc.

K number K970259

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