Neil Medical Group
PRE Connected Foley Tray With BAG 14FR
11manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Anhui Careplus Medical Technology Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Zhangzhou Aoxi Plastic Co., Ltd. | Zhangzhou | Fujian | Manufacturer | 7 |
| Well Care (Wuhan) Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
Record
| Listed by | Neil Medical Group, United States |
|---|---|
| FDA product code | FCN |
| Device type | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2025-12-08 |
| Record revised | 2026-06-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2005-14FR | In distribution | |
| 2005-18FR | In distribution | |
| 2005-16FR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health | 16 |
| Dover | Cardinal Health 200, LLC | 12 |
| Cook | Cook Incorporated | 10 |
| SteriGear | SteriGear, LLC | 6 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
| Neomed* | Avanos Medical, Inc. | 5 |
| ProCure | Twin Med, LLC | 4 |
| Surgyco | Surgyco LLC | 3 |
| LSL Healthcare | Lsl Industries, Inc. | 2 |
| Medline | Medline Industries, Inc. | 2 |
| BioFlo | Insert Molding Solutions, Inc. | 1 |
| TruCath | HR Pharmaceuticals Inc. | 1 |
Showing 12 of 17. All products under Urinary Drainage Collection Kit, For Indwelling Catheter
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.