Z-800WF
Catalogue number Z-800WF, listed by Zyno Medical LLC., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
9recalls on this 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 | Zyno Medical LLC., United States |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K130690 |
| Record published | 2015-10-13 |
| Record revised | 2022-07-04 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Packaging | Box of 4, box of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Z-800WF | 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 |
|---|---|
| K153193 | 2016-08-30 |
| K140783 | 2014-10-17 |
| K130690 | 2013-06-12 |
| K100705 | 2010-07-08 |
| K071545 | 2007-10-31 |
Recalls Naming This Product
9 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 |
|---|---|---|---|---|---|---|
| Zyno Medical LLC. | 510(k) number | 2025-05-07 | Class I | Software design (manufacturing process) | Unreleased software versions were installed on distributed devices without verification or validation. | 613 units |
| Zyno Medical LLC. | 510(k) number | 2025-05-07 | Class I | Software design (manufacturing process) | Unreleased software versions were installed on distributed devices without verification or validation. | 613 units |
| Zyno Medical LLC. | 510(k) number | 2025-05-07 | Class I | Software design (manufacturing process) | Unreleased software versions were installed on distributed devices without verification or validation. | 613 units |
| Zyno Medical LLC. | 510(k) number | 2025-05-07 | Class I | Software design (manufacturing process) | Unreleased software versions were installed on distributed devices without verification or validation. | 613 units |
| Zyno Medical LLC. | 510(k) number | 2024-10-18 | Class II | Device Design | Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains. | 34,994 units |
| Zyno Medical LLC. | 510(k) number | 2024-09-30 | Class III | Software design (manufacturing process) | For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024. | 100 units |
| Zyno Medical LLC. | 510(k) number | 2024-09-13 | Class I | Process change control | There is a defect in the air-in-line software algorithm. | 34,994 units (1819 units still need correction) |
| Zyno Medical LLC. | 510(k) number | 2024-06-04 | Class II | Process control | Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no cha | 88 units |
| Zyno Medical LLC. | 510(k) number | 2023-12-20 | Class II | Software design | When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme | 574 units |
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.