McKesson
Cap, Disinfecting for Needle Free Valves, Strip of 10
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Record
| Listed by | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | QBP |
| Device type | Cap, Device Disinfectant |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| 510(k) | K130975 |
| Record published | 2022-11-10 |
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 | Case of 10, box of 25, case of 8 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 421-SCXT3-2000 | 200 | In distribution | |
| 421-SCXT3-10-2000 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DualCap® | Merit Medical Systems, Inc. | 7 |
| SwabCap™ | ICU Medical, Inc | 2 |
| BD PureHub | Becton, Dickinson AND Company | 2 |
| SwabSleeve™ | ICU Medical, Inc | 1 |
| SwabTip™ | ICU Medical, Inc | 1 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2025-06-16 | Class II | Process control | SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced le | 1,427,100 eaches |
| ICU Medical, Inc | 510(k) number | 2025-06-03 | Class II | Process control | Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequ | 1,445,600 |
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.