Acta Medical
500ml EVA bag with two way valve
7manufacturers in China registered for this device type
17catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Wanying Health & Technology (Zhongshan) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Yangzhou Weideli Trading Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 10 |
| Beijing L&Z Medical Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Acta Medical, LLC, United States |
|---|---|
| FDA product code | KPE |
| Device type | Container, I.V. |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5025 |
| Record published | 2022-08-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACTAMIX2000 | In distribution | |
| ACTA2P0100 | In distribution | |
| ACTA2P0500 | In distribution | |
| ACTAMIX0250 | In distribution | |
| AMA0500V | In distribution | |
| ACTAMIX3000 | In distribution | |
| ACTAMIX1000 | In distribution | |
| AMA0250V | In distribution | |
| ACTA2P0250 | In distribution | |
| ACTAMIX0150 | In distribution | |
| ACTAMIX4000 | In distribution | |
| ACTAMIX0500 | In distribution | |
| AMA0150HS | In distribution | |
| AMA0250 | In distribution | |
| AMA0150HSV | In distribution | |
| AMA0105 | In distribution | |
| AMA0500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ChemoPlus | Cardinal Health | 54 |
| Secure® | Metrix Company, THE | 46 |
| EVA TPN Bags | Valmed SRL | 45 |
| ChemoPlus | Cardinal Health 200, LLC | 44 |
| Container, I.V. | Metrix Company, THE | 27 |
| EcoFLX™ Empty Mixing Container | Douglas Medical Products, Inc | 22 |
| Cormix | Metrix Company, THE | 21 |
| PiSA BioPharm | Pisa Biopharm Inc. | 20 |
| Pinnacle® | B. Braun Medical Inc. | 20 |
| Apex® | B. Braun Medical Inc. | 18 |
| McKesson | Mckesson Medical-Surgical Inc. | 14 |
| eZSURE™ | Epic International (Thailand) Co., Ltd. | 14 |
Showing 12 of 59. All products under Container, I.V.
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121161 | 2012-07-13 |
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.