8MFA Flowmeters
8MFA Series,flowmeter,compact,w/NEB BLK
9manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Precision Medical Technologies, United States |
|---|---|
| FDA product code | CAX |
| Device type | Flowmeter, Tube, Thorpe, Back-Pressure Compensated |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2340 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2021-04-19 |
| Record revised | 2026-06-11 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2026-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8MFA7000 SERIES | Withdrawn | |
| 8MFA6000 SERIES | Withdrawn | |
| 8MFA O2 Series | Withdrawn | |
| 8MFA Air Series | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K854067 | 1985-10-29 |
| K850559 | 1985-04-25 |
| K850560 | 1985-04-17 |
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.