VITAL Tubing Sets for Hemodialysis

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 23 Oct 2026.

Trade Name

Tubing Sets for Hemodialysis EUDAMED

Vital GUDID

Generic Name

Haemodialysis blood tubing set, single-use

Model / Reference

BLU003B, BLU005B, BLU006E, BLU007E, BLU012G, BLU004E

Primary DI / UDI-DI

09555793101256 EUDAMED

09551019763222 EUDAMED

09551019767879 EUDAMED

09555793100945 EUDAMED

09555793100938 EUDAMED

09555793101119 EUDAMED

09551019766230 EUDAMED

09555793100914 GUDID

Basic UDI-DI

B-09555793101256, B-09551019763222, B-09551019767879, B-09555793100945, B-09555793100938, B-09555793101119, B-09551019766230

510(k) Number

K251341 ↗

FDA Product Code

FJK

EMDN Code

F020102 Arteriovenous dialysis lines, two needles

GMDN Term

Haemodialysis blood tubing set, single-use

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 876.5820

EU market of registration

Germany

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Tubing Sets for Hemodialysis

  Class IIa

  CE/MDD

• Disposable AV Fistula Needle Sets

  Class IIa

  CE/MDD

• Disposable AV Fistula Needle Sets (Safety Needle Series)

  Class IIa

  CE/MDD

• FRESENIUS MEDICAL CARE Disposable AV Fistula Needle Sets (Safety Needle Series)

  Class IIa

  CE/MDD

• Disposable AV Fistula Needle Sets (Dull Needle Series)

  Class IIa

  CE/MDD

• Disposable AV Fistula Needle Sets

  Class IIa

  CE/MDD

See all devices from Vital Healthcare Sdn. Bhd. →

• Are these tubing sets reusable or designed for single-use in hemodialysis procedures, and how should they be handled to maintain sterility?

  The Vital Tubing Sets for Hemodialysis are explicitly designed for single-use only. They are supplied sterile, and proper storage and handling are critical to preserve sterility and functionality. Since they are intended for extracorporeal blood flow during hemodialysis, reuse would violate sterility and safety standards, posing risks of infection or contamination. Always follow manufacturer guidelines for opening, use, and disposal to ensure compliance with regulatory requirements.

• What types of configurations or variations exist within the Vital Tubing Sets for Hemodialysis, and how are they identified?

  The Vital Tubing Sets come in multiple configurations, including versions with and without anti-regurgitation valves, as indicated by their regulatory categorization under blood tubing sets. These variations are identified by a range of FEI numbers (e.g., 3002974635, 3032828299) and registration numbers (e.g., 3005162618). Each FEI number corresponds to a specific model or variant, ensuring compatibility with different hemodialysis systems or patient needs.

• How should these tubing sets be stored to ensure they remain effective and compliant with regulatory standards?

  The Vital Tubing Sets must be stored according to manufacturer instructions to maintain sterility and functionality. While the data does not specify exact storage conditions (e.g., temperature or humidity), the sets are supplied sterile and intended for single-use, so they should be kept in their original, sealed packaging until use. Exposure to moisture, contamination, or physical damage could compromise their integrity, so avoid storing them in environments with high dust, heat, or direct sunlight.

• What regulatory pathways have these tubing sets undergone, and what does that mean for clinicians or buyers?

  The Vital Tubing Sets for Hemodialysis have undergone FDA 510(k) clearance and comply with MDD (Medical Device Directive) regulations, confirming they meet U.S. and European safety and performance standards. The clearance was granted under the Gastroenterology and Urology advisory committees, though this reflects the filing classification (not an indication) and confirms the device’s classification as Class II under FDA regulations. Clinicians or buyers can rely on this regulatory backing to ensure the sets meet established performance criteria for hemodialysis circuits.