EM
Minilator, NO Orifice
5manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Danyang Xinya Valve Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 17 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Danyang Airtech Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 7 |
| Yuyao Jiahua Medical Appliance, Co., Ltd. | Yuyao | Zhejiang | Manufacturer | 5 |
| Foshan Kycare Medical Equipment Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Allied Medical LLC, United States |
|---|---|
| FDA product code | BXY |
| Device type | Flowmeter, Calibration, Gas |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K860516 |
| Record published | 2024-09-16 |
| Record revised | 2025-10-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L419-020 | In distribution | |
| L419-010 | In distribution | |
| L419 | In distribution | |
| L419-030 | In distribution | |
| L419-050 | In distribution | |
| L543 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Manifold | Maxtec, LLC | 10 |
| DFB Flowmeter | Maxtec, LLC | 10 |
| Acrylic Flowmeter | Maxtec, LLC | 10 |
| Flowmeter | Maxtec, LLC | 4 |
| BlenderBuddy | Maxtec, LLC | 3 |
| Repair Parts | Sunset Healthcare Solutions, Inc. | 3 |
| Responsive Respiratory, Inc. | Responsive Respiratory Inc. | 3 |
| Flowmeter, Calibration, Gas | Salter Labs | 3 |
| Flowmeter Manifold | Maxtec, LLC | 3 |
| SureFlow | Caire Inc. | 3 |
| Flotec | Flotec, Inc. | 1 |
| Flow Sensor, Adult | Besmed Health Business Corporation | 1 |
Showing 12 of 29. All products under Flowmeter, Calibration, Gas
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.