Apex®
EVA Single-Chamber Final Containers 2000 mL
7manufacturers in China registered for this device type
18catalogue numbers in this listing
2510(k) clearances naming this product code
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 | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | KPE |
| Device type | Container, I.V. |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5025 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2022-11-21 |
| Record revised | 2020-09-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 8, carton of 40, carton of 20, carton of 6, carton of 5, carton of 25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2112626 | Capacity (ml) : 4000.000 ML | In distribution | |
| 2112528 | 5 | In distribution | |
| 2112531 | 5 | In distribution | |
| 2112622 | Capacity (ml) : 3000.000 ML | In distribution | |
| 2112529 | 5 | In distribution | |
| 2112625 | Capacity (ml) : 3000.000 ML | In distribution | |
| 2112620 | Capacity (ml) : 1000.000 ML | In distribution | |
| 2112532 | 5 | In distribution | |
| 2112619 | Capacity (ml) : 500.000 ML | In distribution | |
| 2112621 | Capacity (ml) : 2000.000 ML | In distribution | |
| 2112536 | 7 | In distribution | |
| 2112533 | 5 | In distribution | |
| 2112535 | 7 | In distribution | |
| 2112623 | Capacity (ml) : 4000.000 ML | In distribution | |
| 2112618 | Capacity (ml) : 250.000 ML | In distribution | |
| 2112530 | 5 | In distribution | |
| 2112534 | 7 | In distribution | |
| 2112624 | Capacity (ml) : 1500.000 ML | 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 |
| Acta Medical | Acta Medical, LLC | 17 |
| 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 |
|---|---|
| K073538 | 2008-03-12 |
| K041415 | 2004-08-04 |
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.