InfuseOne
3000ml ICU Medical InfuseOne Pressure Infusion Bag
25manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
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 | Ethox Corp., United States |
|---|---|
| FDA product code | KZD |
| Device type | Infusor, Pressure, For I.V. Bags |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5420 |
| Premarket notification | Exempt |
| Record published | 2024-07-01 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 25, box of 5 |
| Sizes | Total volume 3000 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 42357-01 | Total Volume 3000 ml | In distribution |
| 42357-01H | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K894927 | 1989-09-11 |
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.