Ballard™
Ballard™ Mini-BAL Sampling Catheter
1manufacturer
2catalogue 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 | SunMed Group Holdings, LLC, United States |
|---|---|
| FDA product code | OYI |
| Device type | Non-Bronchoscopic Bronchoalveolar Lavage Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 868.6810 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-11-17 |
| Record revised | 2026-01-16 (version 2) |
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 |
| Packaging | Case of 5 |
| Sizes | Catheter gauge 13 to 16 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 142 | Catheter Gauge 16 Fr | In distribution |
| 143 | Catheter Gauge 13 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jet Lavage Catheter | Well Lead Medical Co., Ltd. | 6 |
| 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.