Identifiers
- 510(k) Number
- K232875 FDA 510(k)
- FDA Product Code
- LHI 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 Vial Adapter 20mm is a connector device designed to facilitate the transfer of liquids between vials and other compatible systems. It ensures a secure, leak-proof interface for pharmaceutical preparations, maintaining sterility and compatibility with standard vial sizes.
This adapter is supplied as a single-use component, intended for use in hospital or clinical settings where aseptic technique is required. It is manufactured to comply with FDA 510K and MDR regulatory standards, ensuring safety and performance for pharmaceutical applications. The 20mm designation specifies the diameter for compatibility with standard vial necks.
Frequently asked questions
What is the primary purpose of the Vial Adapter 20mm in a clinical setting?
The Vial Adapter 20mm is designed to create a secure, leak-proof connection between vials and compatible systems, enabling safe and sterile transfer of liquids during pharmaceutical preparations. Its 20mm diameter ensures compatibility with standard vial necks, making it ideal for maintaining aseptic technique in hospital or clinical environments.
Is the Vial Adapter 20mm intended for reuse, or is it meant to be used only once?
The Vial Adapter 20mm is explicitly supplied as a single-use component. This design ensures sterility and safety, particularly in settings where aseptic technique is critical, like hospitals or clinical labs.
How do I know if this adapter will fit the vials I’m using in my facility?
The adapter is designed for 20mm diameter vial necks, which aligns with standard pharmaceutical vial sizes. If your vials have a 20mm neck, this adapter should provide a secure, leak-proof connection. Always verify compatibility with your specific vial brand and size before use.
What regulatory standards does the Vial Adapter 20mm comply with, and how does that affect its use?
The adapter complies with FDA 510K and MDR (Medical Device Regulation) standards, confirming its safety and performance for pharmaceutical applications. This means it meets rigorous requirements for design, manufacturing, and sterility, ensuring reliability in clinical settings where aseptic technique is mandatory.
How should the Vial Adapter 20mm be stored to maintain its integrity?
While the specifications don’t detail storage conditions explicitly, as a single-use, sterile medical device, it should be stored in a clean, dry environment protected from contamination. Follow manufacturer guidelines (if available) or standard sterile device storage practices—typically, keep it in its original packaging until use to preserve sterility.
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: Gx® Vials | Pharmafläschchen für Injektionsmittel | Gerresheimer
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 | K232875 | Class II | Active |
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Manufacturer
- Manufacturer
- West Pharma. Services IL, Ltd.
Sources (2)
- FDA 510(k) K232875 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026