Respiratory Adaptor W/Luer Port, Cap
Respiratory Adaptor (15 mm ID x 22 mm OD) w/Luer Port and Female Luer Lock Cap
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Westmed, Inc., United States |
|---|---|
| FDA product code | BXY |
| Device type | Flowmeter, Calibration, Gas |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2350 |
| Establishment | Contract manufacturer, Remanufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-31 |
| Record revised | 2023-05-01 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 50 |
| Distribution end date | 2023-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0400 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Manifold | Maxtec, LLC | 10 |
| DFB Flowmeter | Maxtec, LLC | 10 |
| Acrylic Flowmeter | Maxtec, LLC | 10 |
| EM | Allied Medical LLC | 6 |
| 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 |
Showing 12 of 29. All products under Flowmeter, Calibration, Gas
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K953506 | 1995-09-15 |
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.