Jet Lavage Catheter
10Fr standard tip
1manufacturer
6catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Tongshun Medical Equipment Co., Ltd. | Weifang | Shandong | Contract manufacturer | 2 |
Record
| Listed by | Well Lead Medical Co., Ltd., China |
|---|---|
| FDA product code | OYI |
| Device type | Non-Bronchoscopic Bronchoalveolar Lavage Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 868.6810 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, carton of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A16A011010 | In distribution | |
| A16A021410 | In distribution | |
| A16A011210 | In distribution | |
| A16A021210 | In distribution | |
| A16A011410 | In distribution | |
| A16A021010 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ballard™ | SunMed Group Holdings, LLC | 2 |
| Ballard* Mini-BAL Sampling Catheter | Avanos Medical, Inc. | 2 |
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.