Volumat MC Agilia US
The Volumat MC Agilia US is a transportable infusion pump for intermittent or continuous intravenous delivery of fluids and medications. Trained healthcare professionals use it in…
The Volumat MC Agilia US is a transportable infusion pump for intermittent or continuous intravenous delivery of fluids and medications. Trained healthcare professionals use it in healthcare facilities for adult, pediatric and neonatal patients, following hospital protocols. It can also administer blood products with the required transfusion administration set.
The pump uses a microprocessor-controlled linear peristaltic mechanism. It can be placed on a flat surface or mounted on a rail or pole. Dedicated Volumat Lines administration sets carry the infusion, and sensors detect occlusion upstream and downstream.
Listed Item
The VOLUMAT MC AGILIA US is a transportable equipment intended to be used in healthcare facilities environment by healthcare trained professionals, according to hospital protocols on adults, paediatrics and neonates human patients to administer – intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but not limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration. – transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required.
Multiple Pump Configurations
An optional Agilia Duo accessory joins two pumps. Link+ racks accommodate four, six or eight pumps and centralize power and data communication. Optional Vigilant Drug’Lib software supports configurable drug limits.
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Zyno Electric & Machinery Ltd, Shanghai | Shanghai | Shanghai | Contract manufacturer | 1 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Fresenius Kabi AB, Sweden |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K121613 |
| Record published | 2017-09-29 |
| Record revised | 2022-07-04 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Z021135 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| Flow Control Tubing | GO Medical Industries PTY. Ltd. | 39 |
| Curlin Administration Set | Zevex, Inc. | 30 |
| ambIT | Summit Medical Products, Inc. | 27 |
| Beeline motIV | Rex Pj Tech LLC | 24 |
| RMS Precision Flow Rate TubingTM | Repro-Med Systems, Inc. | 24 |
| Medfusion | ICU Medical, Inc | 24 |
| Volumat™ Line | Fresenius Kabi AB | 24 |
| Outlook® | B. Braun Medical Inc. | 21 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
Showing 12 of 191. All products under Pump, Infusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210074 | 2022-03-01 |
| K210073 | 2022-03-01 |
| K121613 | 2013-05-01 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Fenwal, Inc. | 510(k) number | 2019-06-24 | Class I | Other | The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib | 9461 units | 2023-03-06 |
| Fresenius Vial S.A.S. | 510(k) number | 2017-12-02 | Class II | Software design | Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience while preventing common software malfunctions. | 7082 units | 2021-02-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.