FDA product code PXJ: Umbilical Catheter Insertion Tray
PXJ is the FDA product code for umbilical catheter insertion tray. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel. Devices under PXJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Umbilical Catheter Insertion Tray |
| Device class | Class II |
| Regulation | 21 CFR 880.5200 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for PXJ devices
openFDA lists no recalls for product code PXJ.
Frequently asked questions
What is FDA product code PXJ?
PXJ is the FDA product code for umbilical catheter insertion tray. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel.
What device class is PXJ?
Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PXJ
- Run a recall and safety report across every PXJ manufacturer
- Watch product code PXJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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