SteriGear
Fig Leaf 1000ml Leg Bag 10280
11manufacturers in China registered for this device type
6catalogue numbers in this listing
1recall
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 | SteriGear, LLC, 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 | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-11-17 |
| Record revised | 2021-05-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature |
| Packaging | Pack of 20, pack of 48, pack of 30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REA4001-01 | In distribution | |
| UE4001-00 | In distribution | |
| UE4001-00 | In distribution | |
| UE4001-00 | In distribution | |
| A4092-81 | In distribution | |
| UE4001-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health | 16 |
| Dover | Cardinal Health 200, LLC | 12 |
| Cook | Cook Incorporated | 10 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
| Neomed* | Avanos Medical, Inc. | 5 |
| ProCure | Twin Med, LLC | 4 |
| Surgyco | Surgyco LLC | 3 |
| Neil Medical Group | Neil Medical Group | 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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-01-11 | Class II | Device Design | SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed. | 110,560 | 2015-01-02 |
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.