Vacuflow+safe Blood Collection Set and Vacuflow+safe with Holder Blood Collection Set
510(k) K000714
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000714 | Date21 Dec 2000 | StatusActive |
Recalls
-
- Terminated Z-2870-2016
The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a blood collection set designed for venipuncture procedures, classified under the nomenclature for phlebotomy equipment. It features a vacuum-based system to facilitate blood collection into evacuated tubes, with an integrated safety mechanism to reduce the risk of needlestick injuries during and after use. The set includes both a standard configuration and a variant with a preattached holder for added convenience during collection.
The Vacuflow+ Safe Blood Collection Set is intended for single-use in clinical settings such as hospitals and outpatient facilities. It is supplied sterile and requires no additional preparation beyond standard phlebotomy protocols. The device is regulated under FDA 510(k) clearance (K000714) and adheres to safety standards for blood collection systems, ensuring compliance with medical device regulations. Storage should follow manufacturer guidelines to maintain sterility and functionality.
Other devices from Med-Pro Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Vacuflow+ Safe Blood Collection Set designed for?
The Vacuflow+ Safe Blood Collection Set is specifically designed for venipuncture procedures to collect blood into evacuated tubes using a vacuum-based system. Its primary purpose is to streamline blood collection in clinical settings like hospitals and outpatient facilities while minimizing the risk of needlestick injuries through an integrated safety mechanism.
How is the Vacuflow+ Safe Blood Collection Set supplied, and does it require preparation?
The set is supplied sterile and ready for immediate use in clinical settings. No additional preparation is required beyond adhering to standard phlebotomy protocols, ensuring convenience and efficiency during blood collection procedures.
Is the Vacuflow+ Safe Blood Collection Set intended for single-use or reuse?
This device is explicitly designed for single-use only. Using it more than once violates manufacturer guidelines and compromises sterility, patient safety, and regulatory compliance. Single-use ensures consistent performance and reduces infection risks.
What distinguishes the Vacuflow+ Safe with Holder variant from the standard set?
The Vacuflow+ Safe with Holder variant includes a preattached holder, which provides added stability and convenience during blood collection. This feature helps clinicians maintain better control of the needle and tube during venipuncture, reducing the likelihood of procedural errors or accidental dislodgment.
How should the Vacuflow+ Safe Blood Collection Set be stored to maintain sterility?
Storage must follow the manufacturer’s guidelines to preserve sterility and functionality. Typically, this involves keeping the set in its original, sealed packaging in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Always check the packaging for specific storage instructions before use.