Secure®
Empty EVA Single Chamber Container With 5 Port Manifold Fill SET (10 Sets OF 5 Bags)
7manufacturers in China registered for this device type
46catalogue 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 | Metrix Company, THE |
|---|---|
| FDA product code | KPE |
| Device type | Container, I.V. |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5025 |
| 510(k) | K030888 |
| Record published | 2016-09-24 |
| Record revised | 2019-10-23 (version 6) |
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 | Cardboard carton of 50, cardboard carton of 10, cardboard carton of 8, cardboard carton of 42, cardboard carton of 5 |
| Sizes | Total volume 50 to 4000 ml |
| Distribution end date | 2025-01-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 66045 | Total Volume 250 ml | In distribution | |
| 66653 | Total Volume 3000 ml | 5 | In distribution |
| 66641 | Total Volume 4000 ml | 5 | In distribution |
| 66042 | Total Volume 50 ml | In distribution | |
| 66235 | Total Volume 4000 ml | In distribution | |
| 66615 | Total Volume 1500 ml | In distribution | |
| 66621 | Total Volume 2000 ml | 5 | In distribution |
| 66205 | Total Volume 250 ml | In distribution | |
| 66651 | Total Volume 1000 ml | 5 | In distribution |
| 58719 | Total Volume 100 ml | 40 | In distribution |
| 66215 | Total Volume 1000 ml | In distribution | |
| 58782 | In distribution | ||
| 66040 | Total Volume 100 ml | In distribution | |
| 66135 | Total Volume 4000 ml | In distribution | |
| 58794 | In distribution | ||
| 66105 | Total Volume 2000 ml | In distribution | |
| 66110 | Total Volume 3000 ml | In distribution | |
| 66620 | Total Volume 2000 ml | In distribution | |
| 58786 | 10 | In distribution | |
| 66430 | Total Volume 3000 ml | In distribution | |
| 66120 | Total Volume 1000 ml | In distribution | |
| 58783 | In distribution | ||
| 66425 | Total Volume 2000 ml | In distribution | |
| 66210 | Total Volume 500 ml | In distribution | |
| 66050 | Total Volume 500 ml | In distribution | |
| 66130 | Total Volume 3000 ml | In distribution | |
| 66410 | Total Volume 500 ml | In distribution | |
| 66102 | Total Volume 500 ml | In distribution | |
| 66630 | Total Volume 3000 ml | In distribution | |
| 66055 | Total Volume 1000 ml | In distribution | |
| 66631 | Total Volume 3000 ml | 5 | In distribution |
| 66405 | Total Volume 250 ml | In distribution | |
| 66652 | Total Volume 2000 ml | 5 | In distribution |
| 66654 | Total Volume 4000 ml | 5 | In distribution |
| 66041 | Total Volume 100 ml | 50 | In distribution |
| 66230 | Total Volume 3000 ml | In distribution | |
| 58780 | In distribution | ||
| 66640 | Total Volume 4000 ml | In distribution | |
| 66616 | Total Volume 1500 ml | 5 | In distribution |
| 66043 | Total Volume 50 ml | 50 | In distribution |
| 66225 | Total Volume 2000 ml | In distribution | |
| 66100 | Total Volume 1000 ml | In distribution | |
| 66415 | Total Volume 1000 ml | In distribution | |
| 66435 | Total Volume 4000 ml | In distribution | |
| 66125 | Total Volume 2000 ml | In distribution | |
| 58784 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ChemoPlus | Cardinal Health | 54 |
| 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 |
| McKesson | Mckesson Medical-Surgical Inc. | 14 |
| eZSURE™ | Epic International (Thailand) Co., Ltd. | 14 |
Showing 12 of 59. All products under Container, I.V.
Recalls Naming This Product
25 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 | Closed |
|---|---|---|---|---|---|---|---|
| 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 | |
| THE Metrix Company | 510(k) number | 2018-09-21 | Class II | Process control | Potential for leaking product | 1596 bags | |
| THE Metrix Company | 510(k) number | 2018-09-21 | Class II | Process control | Potential for leaking product | 4284 bags | |
| THE Metrix Company | 510(k) number | 2018-09-21 | Class II | Process control | Potential for leaking product | 1512 bags | |
| THE Metrix Company | 510(k) number | 2018-09-21 | Class II | Process control | Potential for leaking product | 141120 bags | |
| THE Metrix Company | 510(k) number | 2018-09-21 | Class II | Process control | Potential for leaking product | 234720 bags | |
| THE Metrix Company | 510(k) number | 2018-09-21 | Class II | Process control | Potential for leaking product | 54720 bags | |
| THE Metrix Company | 510(k) number | 2018-09-21 | Class II | Process control | Potential for leaking product | 175392 bags | |
| THE Metrix Company | 510(k) number | 2018-09-21 | Class II | Process control | Potential for leaking product | 332640 bags | |
| THE Metrix Company | 510(k) number | 2017-09-13 | Class II | Error in labeling | The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes. | 50 cases of 200 units | 2018-05-25 |
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.