Gesco Dual Lumen Umbilicath II-DL

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K896041 ↗

FDA Product Code

FOS

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SEKD

• Thora-Cath

  Class II

  FDA 510(k) K941232 Active Cleared 11 May 1994

• Per-Q-Cath Tray

  Class II

  FDA 510(k) K831845 Active Cleared 24 Aug 1983

• Gesco per-Q-Cath Repair Kit

  Class II

  FDA 510(k) K910622 Active Cleared 29 Mar 1991

• Umbili-Cath-S

  Class II

  FDA 510(k) K940953 Active Cleared 2 Aug 1994

• Gesco Catheterization Tray

  Class I

  FDA 510(k) K882647 Active Cleared 9 Sep 1988

• Gesco per-Q-Cath Needle

  Class II

  FDA 510(k) K911215 Active Cleared 6 Jun 1991

See all devices from Gesco Intl., Inc. →

• What is the Gesco Dual Lumen Umbilicath II-DL used for?

  The Gesco Dual Lumen Umbilicath II-DL is designed specifically for neonatal umbilical vascular access. It provides two separate pathways within a single catheter, allowing healthcare providers to simultaneously administer fluids or medications, withdraw samples, or monitor vital parameters through umbilical vessels. This dual-lumen design is particularly valuable in neonatal intensive care units (NICUs) where high-risk infants require reliable and efficient vascular access for critical interventions.

• How is the Gesco Dual Lumen Umbilicath II-DL supplied and prepared for use?

  The catheter is supplied sterile and intended for single-use only. This ensures infection control and safety for neonatal patients. Before use, clinicians must follow standard aseptic techniques to prepare the device, including verifying sterility packaging integrity and ensuring compatibility with the neonatal patient’s vascular anatomy. The device does not require additional sterilization or reprocessing.

• Is the Gesco Dual Lumen Umbilicath II-DL reusable?

  No, the Gesco Dual Lumen Umbilicath II-DL is explicitly intended for single-use only. Single-use catheters reduce the risk of contamination and cross-infection, which is critical in neonatal care where patients are highly vulnerable. Reusing this device would violate manufacturer guidelines and could compromise patient safety.

• What regulatory approvals does the Gesco Dual Lumen Umbilicath II-DL hold?

  The Gesco Dual Lumen Umbilicath II-DL is cleared by the FDA under the 510(k) premarket notification process, with clearance number K896041. This classification confirms that the device meets regulatory standards for safety and effectiveness as a Class II medical device. The product code FOS and regulation number 880.5200 further categorize its intended use and compliance framework.

• Are there different sizes or models of the Gesco Dual Lumen Umbilicath II-DL?

  The regulatory data lists multiple registration numbers (e.g., 3002808466, 3009211636), which may correspond to variations in size, length, or other specifications. However, the exact differences between these models are not detailed in the provided information. Clinicians should consult the manufacturer’s labeling or product documentation to confirm the appropriate size or model for a specific neonatal patient’s needs, ensuring compatibility with umbilical vessel dimensions.