MXR-D Flow Meter
Mxr,digital Display,flushmount,universal Fittings, Rear
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Danyang Xinya Valve Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 17 |
| Nantong Kangjinchen Medical Equipment Co., Ltd. | Nantong | Jiangsu | Manufacturer | 17 |
| Gentec (Shanghai) Corporation | Shanghai | Shanghai | Manufacturer | 12 |
| Ningbo Jiangbei Tenso Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 4 |
| Foshan Kycare Medical Equipment Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 3 |
| Longfian Scitech Co., Ltd. | Baoding | Hebei | Manufacturer | 2 |
| Univac Precision Plastics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Parker Hannifin Corp., United States |
|---|---|
| FDA product code | CAX |
| Device type | Flowmeter, Tube, Thorpe, Back-Pressure Compensated |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2340 |
| 510(k) | K062155 |
| Record published | 2016-09-24 |
| Record revised | 2025-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4065D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PC | Allied Medical LLC | 305 |
| Medline | Medline Industries, Inc. | 156 |
| Ohio | Ohio Medical LLC | 139 |
| Flowmeter | Maxtec, LLC | 111 |
| Flowmeter, Thorpe | Ohio Medical LLC | 64 |
| Amvex Flowmeter | GCE, s.r.o. | 60 |
| Western/Scott Fetzer | Western Enterprises, Inc. | 50 |
| Gentec® | Gentec (Shanghai) Corporation | 31 |
| Manifold | Maxtec, LLC | 25 |
| The Harris Products Group | J. W. Harris Co., Inc. | 18 |
| Legacy Flowmeter | Ohio Medical LLC | 14 |
| MediMeter | GCE, s.r.o. | 14 |
Showing 12 of 53. All products under Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Precision Fluidics Division Parker Hannifin Corp. | 510(k) number | 2008-08-26 | Not classified | Employee error | inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas | 220 units | 2010-09-24 |
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.