Merit Medical®
6 catalogue numbers from 00884450331989, listed by Merit Medical Systems, Inc., United States, under Infusor, Pressure, For I.V. Bags. 25 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (9), Zhejiang (6), Jiangsu (4). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Vistar Medical Supplies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Guangzhou AMK Medical Equipment Co., Ltd. | Guang Zhou | Guangdong | Contract manufacturer | 10 |
| Tiantai Shengtengyun Medical Supplies Co., Ltd. | Tiantai County | Zhejiang | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
Showing 12 of 25. All 25 manufacturers in China registered for Infusor, Pressure, For I.V. Bags
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | KZD |
| Device type | Infusor, Pressure, For I.V. Bags |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5420 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-07-30 |
| Record revised | 2025-05-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 4, pack of 12, case of 4, pack of 6 |
| Sizes | Total volume 1000 to 3000 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450331989 | In distribution | |
| 00884450006832 | Volume-500 mL | In distribution |
| 00884450011911 | Volume-1000 mL | In distribution |
| C | Total Volume 3000 ml | In distribution |
| C | Volume-500 mL | In distribution |
| C | Total Volume 1000 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Statcorp Medical | Statcorp, Inc. | 98 |
| Unifuser | Statcorp, Inc. | 29 |
| Infusor, Pressure, For I.V. Bags | VBM Medizintechnik Gmbh | 25 |
| Vital Signs™ | Airlife, Inc. | 13 |
| Ethox | Ethox Corp. | 13 |
| Unifusors | Statcorp, Inc. | 12 |
| Medline | Medline Industries, Inc. | 12 |
| PremierPro | Prestige Ameritech | 10 |
| American Hospital Supply | American Hospital Supply | 9 |
| Biegler | Ningbo Albert Novosino Co., Ltd. | 9 |
| Blueline | Transparent Supply Solutions Ltd. | 8 |
| InfuseIT | Salter Labs | 8 |
Showing 12 of 59. All products under Infusor, Pressure, For I.V. Bags
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-09-29 | Not classified | Other | Potential sterility breach caused by excessive shipment damage. | 24 Infusor bags | 2009-12-15 |
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.