Sterile Blood Administration Set

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

510(k) Number

K780658 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Scalp Vein Sets

  Class II

  FDA 510(k) K772008 Active Cleared 3 Jan 1978

• Solution Administration Set

  Class II

  FDA 510(k) K811006 Active Cleared 2 Jun 1981

• Suru Infusion Set Type J

  Class II

  FDA 510(k) K802169 Active Cleared 6 Apr 1981

• Suru Blood Collection Set

  Class II

  FDA 510(k) K802170 Active Cleared 6 Apr 1981

• Sterile Blood Collection Set

  Class II

  FDA 510(k) K780657 Active Cleared 19 Jul 1978

• Sterile Infusion Set Type J

  Class II

  FDA 510(k) K780656 Active Cleared 19 Jul 1978

See all devices from Suru Chemicals & Pharmaceuticals, Ltd. →

• What is the Sterile Blood Administration Set used for?

  This set is specifically designed for the intravenous infusion of blood or blood components in clinical environments. It ensures controlled and safe delivery from a blood container directly into a patient’s circulatory system, minimizing contamination risks during aseptic procedures. It is not intended for other types of infusions or non-blood fluids.

• Is the Sterile Blood Administration Set reusable or single-use?

  The Sterile Blood Administration Set is intended for single-use only. Reuse is not recommended as it could compromise sterility, increase infection risks, and violate manufacturer guidelines. Each set is packaged sterile and must be discarded after one use to maintain safety standards.

• How should the Sterile Blood Administration Set be stored before use?

  Store the set in a clean, dry place away from direct sunlight and extreme temperatures. Avoid exposure to moisture or contaminants that could compromise its sterility. The packaging should remain intact until immediately before use, and sterile technique must be maintained throughout handling.

• What materials are included in the Sterile Blood Administration Set?

  The set includes tubing, connectors, and a sterile spike or needle adapter, all designed for seamless transfer of blood from its container to the patient. The components adhere to medical-grade standards to prevent leaks, contamination, or damage during infusion. No additional accessories are supplied.

• Can the Sterile Blood Administration Set be used in MRI environments?

  No, the Sterile Blood Administration Set is not intended for MRI use. The materials and construction are not designed to be compatible with magnetic resonance imaging. Always verify device compatibility with MRI protocols before use in such settings.