FDA Product Code
FDA Product Code MRZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 48 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230718 | UTC 3mL Medication Cartridge | Gilero, LLC | 2023-06-15 | Traditional | PDF ↗ |
| K220695 | Elite Biomedical Solutions Dose Request Cord | Elite Biomedical Solutions | 2022-04-29 | Traditional | PDF ↗ |
| K201634 | RG 3ml Medication Cartridge | Chengdu Shifeng Medical Technology Co., Ltd. | 2021-03-26 | Traditional | PDF ↗ |
| K193654 | BlueStar Rx | Welldoc, Inc. | 2020-04-07 | Traditional | PDF ↗ |
| K191910 | SpaceStation MRI | B. Braun Melsugen AG | 2020-03-12 | Traditional | PDF ↗ |
| K190013 | WellDoc BlueStar | Welldoc, Inc. | 2019-11-04 | Traditional | PDF ↗ |
| K173531 | Lockbox for Perfusor Space PCA Infusion Pump | B.Braun Medical, Inc. | 2018-08-02 | Traditional | PDF ↗ |
| K171346 | Sapphire Sets | Icu Medical | 2017-08-25 | Traditional | PDF ↗ |
| K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. | 2017-01-12 | Traditional | PDF ↗ |
| K160492 | Hospira Sapphire Sets | Hospira, Inc. | 2016-12-06 | Traditional | PDF ↗ |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | Welldoc, Inc. | 2016-11-22 | Traditional | PDF ↗ |
| K142374 | ivWatch Model 400 | Ivwatch, LLC | 2015-02-13 | Traditional | PDF ↗ |
| K142333 | SMART LABEL, PROPOFOL | American I.V. Products, Inc. Dba Aiv, Inc. | 2014-12-18 | Traditional | PDF ↗ |
| K141273 | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE | Welldoc, Inc. | 2014-07-08 | Special | PDF ↗ |
| K132618 | ONETOUCH REVEAL | Lifescan, Inc. | 2013-12-16 | Traditional | PDF ↗ |
| K120209 | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE | American I.V. Products, Inc. | 2012-04-12 | Traditional | PDF ↗ |
| K120314 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | Welldoc, Inc. | 2012-02-24 | Special | PDF ↗ |
| K112370 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | Welldoc, Inc. | 2011-10-14 | Special | PDF ↗ |
| K101806 | AIDERA DIASEND SYSTEM | Aidera AB | 2010-12-07 | Traditional | PDF ↗ |
| K100066 | DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 | Welldoc, Inc. | 2010-07-15 | Traditional | PDF ↗ |
| K091181 | LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS | Smiths Medical MD, Inc. | 2009-06-12 | Traditional | PDF ↗ |
| K083221 | AIDERA DIASEND | Aidera AB | 2009-02-03 | Traditional | PDF ↗ |
| K082783 | CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE | Smiths Medical MD, Inc. | 2008-12-17 | Traditional | PDF ↗ |
| K080587 | EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE | Animas Corp. | 2008-05-15 | Traditional | PDF ↗ |
| K080227 | ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM | Roche Diagnostics Corp. | 2008-05-15 | Abbreviated | PDF ↗ |
| K072955 | CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) | Smiths Medical MD, Inc. | 2008-02-13 | Traditional | PDF ↗ |
| K070438 | MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 | Medtronic Minimed, Inc. | 2007-10-17 | Traditional | PDF ↗ |
| K071418 | DANA 3CC SYRINGE INSULIN RESERVOIR | Sooil Development Co., Ltd. | 2007-09-04 | Traditional | PDF ↗ |
| K051079 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY | Hospicare, Inc. | 2005-05-19 | Special | PDF ↗ |
| K030936 | RITA CLIPS FOR INFUSION PUMPS | Rita Medical Systems, Inc. | 2003-04-01 | Traditional | PDF ↗ |
| K023890 | PREPARE CARTRIDGE | Appro Healthcare, Inc. | 2003-02-07 | Traditional | PDF ↗ |
| K021974 | MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311 | Minimed, Inc. | 2002-08-06 | Traditional | PDF ↗ |
| K012259 | MEDFUSION 2001 & 2010, MODEL N7215IWC | National Custom Ent., Inc. | 2001-09-12 | Traditional | PDF ↗ |
| K012266 | SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 | National Custom Ent., Inc. | 2001-09-12 | Traditional | PDF ↗ |
| K012262 | BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC | National Custom Ent., Inc. | 2001-09-12 | Traditional | PDF ↗ |
| K990091 | S.P.A.R STERILE AMBULATORY RESERVOIR | Faulding Pharmaceutical Co. | 1999-04-04 | Traditional | PDF ↗ |
| K980165 | INFUTEST 2000 INFUSION DEVICE ANALYZER | Datrend Systems, Inc. | 1998-04-20 | Traditional | PDF ↗ |
| K961486 | IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT | Ivac Medical Systems | 1998-04-17 | Traditional | PDF ↗ |
| K970678 | THE HARVARD LIBRARY | Harvard Apparatus, Inc. | 1998-01-09 | Traditional | PDF ↗ |
| K972779 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P | Alexander Mfg. Co. | 1997-10-20 | Traditional | PDF ↗ |
| K972780 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 | Alexander Mfg. Co. | 1997-10-20 | Traditional | PDF ↗ |
| K962159 | STERILE AMBULATORY RESERVOIR 60ML/100ML | Faulding Medical Device Co. | 1997-07-18 | Traditional | PDF ↗ |
| K972089 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224 | Alexander Mfg. Co. | 1997-07-03 | Traditional | PDF ↗ |
| K971237 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108 | Alexander Mfg. Co. | 1997-05-27 | Traditional | PDF ↗ |
| K970786 | ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7) | Alexander Mfg. Co. | 1997-05-27 | Traditional | PDF ↗ |
| K971234 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825 | Alexander Mfg. Co. | 1997-05-27 | Traditional | PDF ↗ |
| K971212 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018 | Alexander Mfg. Co. | 1997-05-27 | Traditional | PDF ↗ |
| K971213 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P | Alexander Mfg. Co. | 1997-05-27 | Traditional | PDF ↗ |
Product code MRZ · Class II · General Hospital. Data: openFDA.