Monoject Prefill Heparin Lock Flush Syringe
by Tyco Healthcare 510(k)
Active
510(k) K013556
Overview
The Monoject Prefill Heparin Lock Flush Syringe is a sterile, single-use, prefilled syringe designed for intravenous use. It contains a heparin lock flush solution (10 or 100 USP units/ml) and is classified as a standard piston syringe under FDA nomenclature. This device is intended for maintaining the patency of intravascular access devices and intravenous administration sets.
Used exclusively by healthcare professionals in clinical settings, the syringe provides a ready-to-use delivery mechanism for heparin flush solution. Supplied in sterile packaging, it is intended for single-use only and does not require reprocessing. The device holds an FDA 510(k) clearance (K013556) under the General Hospital advisory committee classification, with no third-party involvement. No MRI safety or reusable specifications are indicated.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013556 | Date31 Dec 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FOZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Tyco Healthcare
Questions
What is the purpose of the Monoject Prefill Heparin Lock Flush Syringe?
The syringe is designed for maintaining the patency of intravascular access devices and intravenous administration sets, providing a ready-to-use delivery mechanism for heparin flush solution in clinical settings.
Is the Monoject Prefill Heparin Lock Flush Syringe reusable?
No, this device is intended for single-use only and does not require reprocessing. It is supplied in sterile packaging and should not be reused for patient safety reasons.
What concentrations of heparin are available in the Monoject Prefill Heparin Lock Flush Syringe?
The syringe contains a heparin lock flush solution in concentrations of either 10 or 100 USP units/ml, depending on the specific product configuration.
How is the Monoject Prefill Heparin Lock Flush Syringe classified by the FDA?
It is classified as a standard piston syringe under FDA nomenclature and holds FDA 510(k) clearance (K013556) under the General Hospital advisory committee classification.