McKesson
BAG, EVA 2-PORT W/O Legs 500ML(50/CS)
7manufacturers in China registered for this device type
14catalogue numbers in this listing
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 | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | KPE |
| Device type | Container, I.V. |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5025 |
| 510(k) | K030888 |
| Record published | 2024-08-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 419-64110 | In distribution | |
| 419-64215 | In distribution | |
| 419-64125 | In distribution | |
| 419-64050 | In distribution | |
| 419-64210 | In distribution | |
| 419-64040 | In distribution | |
| 419-64120 | In distribution | |
| 419-64045 | In distribution | |
| 419-64225 | In distribution | |
| 419-64230 | In distribution | |
| 419-64130 | In distribution | |
| 419-64100 | In distribution | |
| 419-64105 | In distribution | |
| 419-64205 | 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 |
| Acta Medical | Acta Medical, LLC | 17 |
| eZSURE™ | Epic International (Thailand) Co., Ltd. | 14 |
Showing 12 of 59. All products under Container, I.V.
Recalls Naming This Product
16 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 288 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 384 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 1920 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 3456 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 1440 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 2229 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 2549 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 1013 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 83 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 2921 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 1020 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 277 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 768 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 1056 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 864 cases of 50 units |
| THE Metrix Company | 510(k) number | 2024-10-09 | Class II | Under Investigation by firm | A limited number of IV bags have been found to leak during filling. | 96 cases of 50 units |
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.