Nu-Cath Emergency Kit

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

510(k) Number

K850398 ↗

FDA Product Code

FOZ

FDA applicant

Intl. Medical Devices , Ltd.

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Neo-Thor Thoracostomy Kit

  Class II

  FDA 510(k) K913541 Active Cleared 9 Apr 1992

• Pedia-Thor Thoracostomy Kit

  Class II

  FDA 510(k) K913540 Active Cleared 9 Apr 1992

• Respiration Monitor 1000

  Class II

  FDA 510(k) K820778 Active Cleared 3 May 1982

• Nu-Thor Thoracostomy Kit

  Class I

  FDA 510(k) K842666 Active Cleared 20 Sep 1984

• Thoracic Cathter Stylet

  Class I

  FDA 510(k) K913539 Active Cleared 21 Jan 1992

• Weiss Emergency Airway System

  Class II

  FDA 510(k) K790650 Active Cleared 27 Jun 1979

See all devices from Intl. Medical Devices, Ltd. →

• What types of medical procedures is the Nu-Cath Emergency Kit specifically designed for in emergency settings?

  The Nu-Cath Emergency Kit is designed for rapid vascular access in emergency scenarios where immediate intravenous access is critical. It is intended for short-term use (up to 30 days) to administer fluids, draw blood samples, or provide hemodialysis in general hospital settings. Its preassembled, single-use design ensures quick deployment when time is of the essence.

• Is the Nu-Cath Emergency Kit reusable, or is it meant for one-time use only?

  The Nu-Cath Emergency Kit is explicitly designed for one-time use only. It is supplied as a preassembled, sterile assembly, and the manufacturer emphasizes discarding it after use to prevent cross-contamination and maintain sterility. Reuse is not recommended or supported.

• How is the Nu-Cath Emergency Kit regulated, and what does that mean for its use in clinical settings?

  The Nu-Cath Emergency Kit holds an FDA 510(k) clearance (K850398), determined to be *Substantially Equivalent* to a legally marketed device in 1985. This means it meets FDA standards for safety and effectiveness as a short-term intravascular catheter for fluid administration, blood sampling, or hemodialysis. Clinicians can rely on this clearance as evidence of regulatory compliance for its intended use.

• What does the product code *FOZ* indicate about the Nu-Cath Emergency Kit’s classification?

  The product code *FOZ* classifies the Nu-Cath Emergency Kit under intravascular catheters in the FDA’s regulatory system. This categorization confirms it is a therapeutic device for temporary vascular access, distinguishing it from other medical tools like pacemakers or surgical implants. The code aligns with its short-term use (≤30 days) and emergency deployment.

• How should the Nu-Cath Emergency Kit be stored to ensure it remains sterile and functional?

  Since the Nu-Cath Emergency Kit is a single-use, preassembled, sterile device, it should be stored in its original packaging until use. The packaging is designed to preserve sterility, so avoid exposing it to moisture, extreme temperatures, or contamination. Always check the expiration date before use to ensure optimal performance and compliance with sterile field protocols.