Additive Port Cap
The Additive Port Cap provides visible evidence that medication has been added to a compatible Baxter IV container and tamper evidence after closure. It is used on the medication ports of…
The Additive Port Cap provides visible evidence that medication has been added to a compatible Baxter IV container and tamper evidence after closure. It is used on the medication ports of VIAFLEX, INTRAVIA, AVIVA and ALL-IN-ONE EVA containers.
The polypropylene cap snaps over the outside of the medication port after medication is added. Once closed, access to the port causes visible damage to the IV container. The cap’s bright red colour identifies the medication-added state.
Listed Item
“For use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed. Packaged in Non-Sterile Bag of 100, 3 bags per shipper box”
Presentation
The cap does not form part of the fluid pathway. It is supplied non-sterile in bulk packaging and is intended for a single use.
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 | Tech Industries. Inc., United States |
|---|---|
| FDA product code | KPE |
| Device type | Container, I.V. |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5025 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K190305 |
| Record published | 2023-07-12 |
| Record revised | 2026-01-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 6, box of 2, box of 3, box |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 21-02 | 50 | In distribution | |
| 21-01B | 50 | In distribution | |
| 21-00B | 100 | In distribution | |
| 21-00 | 100 | In distribution | |
| 21-00-100 | 100 | In distribution | |
| 21-01B 100 | 50 | In distribution | |
| 21-01 | 50 | In distribution | |
| 21-00B-100 | 100 | In distribution | |
| 21-02 100 | 50 | In distribution | |
| 21-01 100 | 50 | 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 |
| McKesson | Mckesson Medical-Surgical Inc. | 14 |
Showing 12 of 59. All products under Container, I.V.
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190305 | 2019-04-30 |
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.