Angel Wing Safety Blood Collection And Infusion Se
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K912563 FDA 510(k)
- FDA Product Code
- FOZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Angel Wing Safety Blood Collection and Infusion Set is a medical device classified as a blood collection and infusion set. It is designed to facilitate safe and secure blood collection and intravenous infusion procedures, incorporating a protective wing mechanism to prevent accidental dislodgement or needle stick injuries during use. The device integrates with standard blood collection and infusion tubing systems to ensure compatibility with existing hospital workflows.
This set is intended for single-use in clinical settings such as general hospitals, where it is used for routine venipuncture and infusion applications. Supplied sterile and packaged for one-time use, the device adheres to FDA 510(k) clearance (K912563) under the product code FOZ, ensuring compliance with regulatory standards for safety and performance. The design prioritises user safety by minimising risks associated with needle handling and disconnection during 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: Angel Wing Safety Blood Collection and Infusion Se, Angel Wing Safety Blood Collection With Tube Hold. (K920184) — Fda 510 ..., Mbo-Laboratories FDA Filings - FDA.report, FDA Browser - Cleared 510 (K) - ANGEL WING SAFETY BLOOD COLLECTION WITH ..., Covidien Monoject™ Angel Wing™ Blood Collection/Infusion Sets with ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K912563 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mbo Laboratories, Inc.
Sources (1)
- FDA 510(k) K912563 24 fields · synced Oct 1, 2026