BD PureHub Disinfecting Cap
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193190 FDA 510(k)
- FDA Product Code
- QBP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD PureHub Disinfecting Cap is a Device Disinfectant designed as a Cap for needle-free luer connectors. It serves as a physical barrier to reduce contamination risk during intravenous (I.V.) access procedures, ensuring swabbable surfaces remain protected prior to use.
Supplied as single-use, sterile caps, the device is intended for use in general hospital settings. Each unit is packaged in strips of 10, with 30 strips per container (product code: QBP). Compliance is supported by FDA 510(k) clearance and EU MDR authorisation, adhering to regulatory standards for medical device disinfection in vascular access management.
Frequently asked questions
What is the BD PureHub Disinfecting Cap designed to protect during intravenous procedures?
The BD PureHub Disinfecting Cap acts as a physical barrier to reduce contamination risk by protecting swabbable surfaces of needle-free luer connectors prior to use. This ensures that the connection points remain clean and uncontaminated during intravenous access procedures.
How is the BD PureHub Disinfecting Cap packaged and supplied for use?
The device is supplied as single-use, sterile caps in strips of 10 units per strip, with each container holding 30 strips (totaling 300 caps). This packaging ensures sterility and convenience for clinical settings.
Is the BD PureHub Disinfecting Cap reusable, or is it intended for one-time use?
The BD PureHub Disinfecting Cap is explicitly designed for single-use only. This aligns with best practices for infection control in medical settings, ensuring each cap remains sterile and uncontaminated for one procedure.
What regulatory pathways does the BD PureHub Disinfecting Cap follow for approval?
The device has obtained FDA 510(k) clearance and EU MDR authorization, confirming compliance with U.S. and European medical device regulations. These pathways validate its safety and effectiveness for use as a device disinfectant in general hospital settings.
What types of medical facilities is the BD PureHub Disinfecting Cap intended for?
The BD PureHub Disinfecting Cap is specifically intended for use in general hospital settings, as indicated by its regulatory submissions and medical specialty designation. This makes it suitable for standard vascular access management procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD PureHub™ disinfecting cap, BD PureHub™ Disinfecting Caps (30 strips of 10 disinfecting caps), Becton Dickinson – Wikipedia, BD PureHub Disinfecting Caps - 306596 - Vitality Medical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K193190 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (2)
- FDA 510(k) K193190 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026