Volumat™ Line
For use with Agilia VP MC pumps / Volumat MC Agilia pump or gravity only.
5manufacturers in China registered for this device type
24catalogue numbers in this listing
3510(k) clearances naming this product code
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 | 2018-08-28 |
| Record revised | 2024-12-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry. Keep away from sunlight. Store at controlled room temperature. |
| Packaging | Box of 30, box of 10, box of 40 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VL SP40-11 | In distribution | |
| VL SL 00-0 | In distribution | |
| VL ON72-X1 | In distribution | |
| VL PA 92-2 | In distribution | |
| VL PA 92-1 | In distribution | |
| VL TR 00-0 | In distribution | |
| VL PR 42-21 | In distribution | |
| VL SP 22-0 | In distribution | |
| VL PR 72-11 | In distribution | |
| VL PR 42-41 | In distribution | |
| VL PR 22-1 | In distribution | |
| VL SP 62-1 | In distribution | |
| VL PR 42-11 | In distribution | |
| VL ON 72-1 | In distribution | |
| VL PN 02-1 | In distribution | |
| VL SL00-X0 | In distribution | |
| VL ST 02-0 | In distribution | |
| VL PR40-11 | In distribution | |
| VL PR 42-12 | In distribution | |
| VL SL00-XP | In distribution | |
| VL ST10-X0 | In distribution | |
| VL PR44-12 | In distribution | |
| VL ST02-X0 | In distribution | |
| VL ST 10-0 | 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 |
| Outlook® | B. Braun Medical Inc. | 21 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
| Plum | ICU Medical, Inc | 14 |
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.