Accessories, Pump, Infusion

FDA product code MRZ · 45 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5725
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1997-05-27 – 2023-06-15

MRZ 2023-06-15

UTC 3mL Medication Cartridge

Applicant Gilero, LLC

K number K230718

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MRZ 2022-04-29

Elite Biomedical Solutions Dose Request Cord

Applicant Elite Biomedical Solutions

K number K220695

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MRZ 2021-03-26

RG 3ml Medication Cartridge

Applicant Chengdu Shifeng Medical Technology Co., Ltd.

K number K201634

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MRZ 2020-04-07

BlueStar Rx

Applicant Welldoc, Inc.

K number K193654

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MRZ 2020-03-12

SpaceStation MRI

Applicant B. Braun Melsugen AG

K number K191910

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MRZ 2019-11-04

WellDoc BlueStar

Applicant Welldoc, Inc.

K number K190013

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MRZ 2018-08-02

Lockbox for Perfusor Space PCA Infusion Pump

Applicant B.Braun Medical, Inc.

K number K173531

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MRZ 2017-08-25

Sapphire Sets

Applicant Icu Medical

K number K171346

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MRZ 2017-01-12

WellDoc BlueStar, WellDoc BlueStar Rx

Applicant Welldoc, Inc.

K number K162532

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MRZ 2016-12-06

Hospira Sapphire Sets

Applicant Hospira, Inc.

K number K160492

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MRZ 2016-11-22

WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System

Applicant Welldoc, Inc.

K number K162225

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MRZ 2013-12-16

ONETOUCH REVEAL

Applicant Lifescan, Inc.

K number K132618

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MRZ 2012-04-12

PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE

Applicant American I.V. Products, Inc.

K number K120209

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MRZ 2012-02-24

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

Applicant Welldoc, Inc.

K number K120314

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MRZ 2011-10-14

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

Applicant Welldoc, Inc.

K number K112370

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MRZ 2010-12-07

AIDERA DIASEND SYSTEM

Applicant Aidera AB

K number K101806

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MRZ 2010-07-15

DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1

Applicant Welldoc, Inc.

K number K100066

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MRZ 2009-06-12

LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS

Applicant Smiths Medical MD, Inc.

K number K091181

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MRZ 2009-02-03

AIDERA DIASEND

Applicant Aidera AB

K number K083221

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MRZ 2008-12-17

CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE

Applicant Smiths Medical MD, Inc.

K number K082783

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MRZ 2008-05-15

EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE

Applicant Animas Corp.

K number K080587

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MRZ 2008-05-15

ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM

Applicant Roche Diagnostics Corp.

K number K080227

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MRZ 2008-02-13

CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276)

Applicant Smiths Medical MD, Inc.

K number K072955

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MRZ 2007-10-17

MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305

Applicant Medtronic Minimed, Inc.

K number K070438

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MRZ 2007-09-04

DANA 3CC SYRINGE INSULIN RESERVOIR

Applicant Sooil Development Co., Ltd.

K number K071418

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MRZ 2005-05-19

HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY

Applicant Hospicare, Inc.

K number K051079

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MRZ 2003-04-01

RITA CLIPS FOR INFUSION PUMPS

Applicant Rita Medical Systems, Inc.

K number K030936

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MRZ 2003-02-07

PREPARE CARTRIDGE

Applicant Appro Healthcare, Inc.

K number K023890

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MRZ 2002-08-06

MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311

Applicant Minimed, Inc.

K number K021974

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MRZ 2001-09-12

SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2

Applicant National Custom Ent., Inc.

K number K012266

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MRZ 2001-09-12

BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC

Applicant National Custom Ent., Inc.

K number K012262

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MRZ 2001-09-12

MEDFUSION 2001 & 2010, MODEL N7215IWC

Applicant National Custom Ent., Inc.

K number K012259

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MRZ 1999-04-04

S.P.A.R STERILE AMBULATORY RESERVOIR

Applicant Faulding Pharmaceutical Co.

K number K990091

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MRZ 1998-04-20

INFUTEST 2000 INFUSION DEVICE ANALYZER

Applicant Datrend Systems, Inc.

K number K980165

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MRZ 1998-04-17

IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT

Applicant Ivac Medical Systems

K number K961486

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MRZ 1998-01-09

THE HARVARD LIBRARY

Applicant Harvard Apparatus, Inc.

K number K970678

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MRZ 1997-10-20

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625

Applicant Alexander Mfg. Co.

K number K972780

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MRZ 1997-10-20

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P

Applicant Alexander Mfg. Co.

K number K972779

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MRZ 1997-07-18

STERILE AMBULATORY RESERVOIR 60ML/100ML

Applicant Faulding Medical Device Co.

K number K962159

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MRZ 1997-07-03

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224

Applicant Alexander Mfg. Co.

K number K972089

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MRZ 1997-05-27

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108

Applicant Alexander Mfg. Co.

K number K971237

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MRZ 1997-05-27

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825

Applicant Alexander Mfg. Co.

K number K971234

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MRZ 1997-05-27

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P

Applicant Alexander Mfg. Co.

K number K971213

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MRZ 1997-05-27

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018

Applicant Alexander Mfg. Co.

K number K971212

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MRZ 1997-05-27

ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7)

Applicant Alexander Mfg. Co.

K number K970786

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