Skip to content

Blood Collection Set, Sterile, Dispos.

by Marbex, Inc.

510(k) K841187

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK841187 Date22 Jun 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BRZ
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Blood Collection Set is a sterile, disposable device used for collecting blood samples. It is designed for single-use blood collection procedures in a general hospital setting.

This device is supplied sterile and is intended for single-use only. It is MRI safe and available in various sizes. The device has FDA 510(k) clearance with product code BRZ and was authorized on June 22, 1984.

Other devices from Marbex, Inc.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Blood Collection Set used for?

    The Blood Collection Set is a sterile, disposable device designed specifically for collecting blood samples in a general hospital setting. It is intended for single-use blood collection procedures to ensure patient safety and prevent cross-contamination.

  • Is the Blood Collection Set reusable or single-use only?

    The Blood Collection Set is supplied sterile and is intended for single-use only. This design ensures sterility for each procedure and eliminates the risk of cross-contamination between patients, which is critical in medical settings.

  • What sizes and models are available for the Blood Collection Set?

    The Blood Collection Set is available in various sizes to accommodate different clinical needs. While specific dimensions aren't provided in the device data, the multiple size options allow healthcare providers to select the appropriate device for their particular blood collection requirements.

  • What is the regulatory status of the Blood Collection Set?

    The Blood Collection Set has FDA 510(k) clearance with product code BRZ. It was authorized on June 22, 1984, and is classified as substantially equivalent to predicate devices. The device is MRI safe, making it suitable for use in environments with magnetic resonance imaging equipment.