"For use on the medication port of ICU Medical LifeCare ® to provide both visual evidence that medication has been added and tamper evidence once the device is closed. Packaged in…
“For use on the medication port of ICU Medical LifeCare ® to provide both visual evidence that medication has been added and tamper evidence once the device is closed. Packaged in Non-Sterile Bags of 50, 2 bags per shipper box”
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.
Record
Regulatory record for Tamper Evident Additive Port Cap | 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 | 2022-10-10 |
| Record revised | 2026-01-15 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box of 2, box of 6 |
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.