BD Emerald Saf-T Single Use Hypodermic
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121283 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Emerald Saf-T Single Use Hypodermic is a single-use hypodermic syringe designed for aspiration and injection of fluids. It is classified as a disposable syringe intended for general medical use, ensuring safe and sterile administration of medications or fluids in clinical settings.
This device is supplied as a sterile, single-use item and is intended for use by healthcare professionals in hospital environments. It is regulated under FDA 510(k) clearance (K121283) and is manufactured by Becton, Dickinson and Company. No reusable or MRI-compatible variants are specified, and storage conditions are not detailed in the provided data.
Frequently asked questions
Is the BD Emerald Saf-T Single Use Hypodermic syringe reusable or meant for single-use only, and how does that affect its safety and sterility?
The BD Emerald Saf-T Single Use Hypodermic is explicitly designed for single-use only, ensuring sterility and safety per its classification as a disposable syringe. Since it is not intended for reuse, there is no risk of cross-contamination between patients, which is critical for infection control in clinical settings. The manufacturer emphasizes its sterile packaging to support safe administration of medications or fluids in hospital environments.
What types of clinical environments or procedures is this syringe typically used for, and why is it considered suitable for general medical use?
The BD Emerald Saf-T Single Use Hypodermic is intended for general medical use, particularly in hospital environments, where healthcare professionals administer medications, fluids, or perform aspirations. Its classification under FDA 510(k) clearance (K121283) and designation as a disposable syringe ensures it meets regulatory standards for safe, sterile, and reliable use in routine clinical procedures like injections, infusions, or diagnostic fluid extraction.
Are there different sizes or models available for this syringe, and if so, how would a clinician determine the appropriate one for their patient?
The provided data does not specify exact sizes or models of the BD Emerald Saf-T Single Use Hypodermic, but as a hypodermic syringe, it likely follows standard volume ranges (e.g., 1 mL, 3 mL, 5 mL, or 10 mL) common in clinical practice. Clinicians would typically select the size based on the volume of fluid to be administered or aspirated, patient-specific needs, and procedural requirements. For precise guidance, consulting the manufacturer’s product documentation or catalog would be advisable.
How should this syringe be stored, and what precautions should be taken to maintain its sterility before use?
While the data does not detail storage conditions explicitly, as a sterile, single-use device, the BD Emerald Saf-T Hypodermic should be stored in its original, unopened packaging to preserve sterility. It should be kept in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Healthcare facilities should follow standard protocols for syringe storage, such as in a sealed cabinet or sterile tray, to prevent exposure to airborne particles or moisture before use.
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 EMERALD SAF-T SINGLE USE, HYPODERMIC - Innolitics, PDF K121283 - Bd Emerald Saf-t Single Use, Hypodermic, BD (company) - Wikipedia, BD EMERALD SINGLE USE, HYPODERMIC SYRINGE by BECTON DICKINSON | FDA 510 ..., BD EMERALD SAF-T SINGLE USE, HYPODERMIC 510(k) K121283 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121283 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K121283 24 fields · synced Sep 18, 2026