Gentec®
FM897A Series, Flowmeter with humidifier, Oxygen, Aluminum, 1L,3L,6L,15L,50L,70L.
9manufacturers in China registered for this device type
31catalogue numbers in this listing
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 | Gentec (Shanghai) Corporation, China |
|---|---|
| FDA product code | CAX |
| Device type | Flowmeter, Tube, Thorpe, Back-Pressure Compensated |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2340 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-11-16 |
| Record revised | 2024-12-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Packaging | Pack of 4 |
| Distribution end date | 2034-11-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FMD197A Series | In distribution | |
| FMD197A Series | In distribution | |
| FM197A-15L-PB | In distribution | |
| FM293 Series Oxygen | In distribution | |
| O-W200-F70-BS | In distribution | |
| FM197A-15L-00 | In distribution | |
| FM197A-8L-00 | In distribution | |
| FM293 Series Air | In distribution | |
| O-W200-F70-GS | In distribution | |
| FM197A-15L-OH-PT | In distribution | |
| FM887A Series | In distribution | |
| FM197A-15L | In distribution | |
| O-G200-F70-DS | In distribution | |
| FM897B Series | In distribution | |
| FM897A Series | In distribution | |
| FM197A-15L-DS | In distribution | |
| FM897A-15L-DS | In distribution | |
| FM887B Series | In distribution | |
| FM197A Series | In distribution | |
| FM197A-3L | In distribution | |
| FMD197B Series | In distribution | |
| FM197A-15L-OH | In distribution | |
| FM197A-6L | In distribution | |
| FM197B Series | In distribution | |
| FM187A Series | In distribution | |
| FMD187A Series | In distribution | |
| FMD187B Series | In distribution | |
| O-W200-F70-DS | In distribution | |
| FM187B Series | In distribution | |
| O-W200-F70 Series | Withdrawn | |
| FM197A -70L-HS 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 |
| 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 |
| 1MFA Flowmeters | Precision Medical Technologies | 9 |
Showing 12 of 53. All products under Flowmeter, Tube, Thorpe, Back-Pressure Compensated
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.