MRZ · Accessories, Pump, Infusion
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | MRZ |
|---|---|
| Device Name | Accessories, Pump, Infusion |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 48)
Showing 20 most recent of 48 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230718 | UTC 3mL Medication Cartridge | Gilero, LLC | Jun 15, 2023 | SESE |
| K220695 | Elite Biomedical Solutions Dose Request Cord | Elite Biomedical Solutions | Apr 29, 2022 | SESE |
| K201634 | RG 3ml Medication Cartridge | Chengdu Shifeng Medical Technology Co., Ltd. | Mar 26, 2021 | SESE |
| K193654 | BlueStar Rx | Welldoc, Inc. | Apr 7, 2020 | SESE |
| K191910 | SpaceStation MRI | B. Braun Melsugen AG | Mar 12, 2020 | SESE |
| K190013 | WellDoc BlueStar | Welldoc, Inc. | Nov 4, 2019 | SESE |
| K173531 | Lockbox for Perfusor Space PCA Infusion Pump | B.Braun Medical, Inc. | Aug 2, 2018 | SESE |
| K171346 | Sapphire Sets | Icu Medical | Aug 25, 2017 | SESE |
| K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. | Jan 12, 2017 | SESE |
| K160492 | Hospira Sapphire Sets | Hospira, Inc. | Dec 6, 2016 | SESE |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | Welldoc, Inc. | Nov 22, 2016 | SESE |
| K142374 | ivWatch Model 400 | Ivwatch, LLC | Feb 13, 2015 | SESE |
| K142333 | SMART LABEL, PROPOFOL | American I.V. Products, Inc. Dba Aiv, Inc. | Dec 18, 2014 | SESE |
| K141273 | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE | Welldoc, Inc. | Jul 8, 2014 | SESE |
| K132618 | ONETOUCH REVEAL | Lifescan, Inc. | Dec 16, 2013 | SESE |
| K120209 | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE | American I.V. Products, Inc. | Apr 12, 2012 | SESE |
| K120314 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | Welldoc, Inc. | Feb 24, 2012 | SESE |
| K112370 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | Welldoc, Inc. | Oct 14, 2011 | SESE |
| K101806 | AIDERA DIASEND SYSTEM | Aidera AB | Dec 7, 2010 | SESE |
| K100066 | DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 | Welldoc, Inc. | Jul 15, 2010 | SESE |
Top Applicants
- Alexander Mfg. Co. — 8 clearances
- Welldoc, Inc. — 8 clearances
- National Custom Ent., Inc. — 3 clearances
- Smiths Medical MD, Inc. — 3 clearances
- Aidera AB — 2 clearances
