Product code MRZ
- Device name
- Accessories, Pump, Infusion
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5725
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230718 | UTC 3mL Medication Cartridge | Gilero, LLC | 2023-06-15 |
| K220695 | Elite Biomedical Solutions Dose Request Cord | Elite Biomedical Solutions | 2022-04-29 |
| K201634 | RG 3ml Medication Cartridge | Chengdu Shifeng Medical Technology Co., Ltd. | 2021-03-26 |
| K193654 | BlueStar Rx | Welldoc, Inc. | 2020-04-07 |
| K191910 | SpaceStation MRI | B. Braun Melsugen AG | 2020-03-12 |
| K190013 | WellDoc BlueStar | Welldoc, Inc. | 2019-11-04 |
| K173531 | Lockbox for Perfusor Space PCA Infusion Pump | B.Braun Medical, Inc. | 2018-08-02 |
| K171346 | Sapphire Sets | Icu Medical | 2017-08-25 |
| K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. | 2017-01-12 |
| K160492 | Hospira Sapphire Sets | Hospira, Inc. | 2016-12-06 |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | Welldoc, Inc. | 2016-11-22 |
| K142374 | ivWatch Model 400 | Ivwatch, LLC | 2015-02-13 |
| K142333 | SMART LABEL, PROPOFOL | American I.V. Products, Inc. Dba Aiv, Inc. | 2014-12-18 |
| K141273 | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE | Welldoc, Inc. | 2014-07-08 |
| K132618 | ONETOUCH REVEAL | Lifescan, Inc. | 2013-12-16 |
| K120209 | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE | American I.V. Products, Inc. | 2012-04-12 |
| K120314 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | Welldoc, Inc. | 2012-02-24 |
| K112370 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | Welldoc, Inc. | 2011-10-14 |
| K101806 | AIDERA DIASEND SYSTEM | Aidera AB | 2010-12-07 |
| K100066 | DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 | Welldoc, Inc. | 2010-07-15 |
| K091181 | LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS | Smiths Medical MD, Inc. | 2009-06-12 |
| K083221 | AIDERA DIASEND | Aidera AB | 2009-02-03 |
| K082783 | CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE | Smiths Medical MD, Inc. | 2008-12-17 |
| K080587 | EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE | Animas Corp. | 2008-05-15 |
| K080227 | ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM | Roche Diagnostics Corp. | 2008-05-15 |
| K072955 | CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) | Smiths Medical MD, Inc. | 2008-02-13 |
| K070438 | MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 | Medtronic Minimed, Inc. | 2007-10-17 |
| K071418 | DANA 3CC SYRINGE INSULIN RESERVOIR | Sooil Development Co., Ltd. | 2007-09-04 |
| K051079 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY | Hospicare, Inc. | 2005-05-19 |
| K030936 | RITA CLIPS FOR INFUSION PUMPS | Rita Medical Systems, Inc. | 2003-04-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10610586043307 | Medfusion | ICU MEDICAL, INC. | 2022-03-29 |
| 10887787007265 | Sapphire | ICU Medical, Inc. | 2018-06-04 |
| 10887787007401 | Sapphire | ICU Medical, Inc. | 2018-06-04 |
| 10887787007395 | Sapphire | ICU Medical, Inc. | 2018-06-04 |
| 10887787007364 | Sapphire | ICU Medical, Inc. | 2018-06-04 |
| 10887787007357 | Sapphire | ICU Medical, Inc. | 2018-06-04 |
| 10887787007319 | Sapphire | ICU Medical, Inc. | 2018-06-04 |
| 10887787007302 | Sapphire | ICU Medical, Inc. | 2018-06-04 |
| 10887787007272 | Sapphire | ICU Medical, Inc. | 2018-06-04 |
| 10610586043628 | CADD | ICU MEDICAL, INC. | 2017-09-01 |
| 10887787007388 | Sapphire | ICU Medical, Inc. | 2017-01-31 |
| 10887787007371 | Sapphire | ICU Medical, Inc. | 2017-01-31 |
| 10887787006503 | Sapphire | ICU Medical, Inc. | 2017-01-31 |
| 10887787007289 | Sapphire | ICU Medical, Inc. | 2017-01-31 |
| 10887787007296 | Sapphire | ICU Medical, Inc. | 2017-01-31 |
| 10887787007340 | Sapphire | ICU Medical, Inc. | 2017-01-31 |
| 10887787007333 | Sapphire | ICU Medical, Inc. | 2017-01-31 |
| 10887787007326 | Sapphire | ICU Medical, Inc. | 2017-01-31 |
| 10610586043017 | Medfusion | ICU MEDICAL, INC. | 2016-11-16 |
| 10610586039812 | Medfusion | ICU MEDICAL, INC. | 2016-11-16 |
| 10610586040092 | Medfusion | ICU MEDICAL, INC. | 2016-11-16 |
| 10610586040108 | Medfusion | ICU MEDICAL, INC. | 2016-11-16 |
| 10610586040818 | Medfusion | ICU MEDICAL, INC. | 2016-11-16 |
| 10610586041242 | Medfusion | ICU MEDICAL, INC. | 2016-11-16 |
| 10610586042423 | Medfusion | ICU MEDICAL, INC. | 2016-11-16 |
| 10610586043581 | Medfusion | ICU MEDICAL, INC. | 2016-11-16 |
| 10610586042799 | Medfusion | ICU MEDICAL, INC. | 2016-11-16 |
| 10610586042867 | Medfusion | ICU MEDICAL, INC. | 2016-11-16 |
| 08809220581045 | DANA Diabecare | SOOIL DEVELOPMENT CO.,LTD | 2016-10-06 |
| 08809220580765 | DANA 3cc Syringe | SOOIL DEVELOPMENT CO.,LTD | 2016-08-12 |