Tubing Sets

Tubing Sets

Name

Tubing Set TS-915

Tubing Set TS-917

Tubing Set MS-18L

Tubing Set TS-2-ML-6

Tubing Set TS-2TLC-50

Order Number

3801 (with syringe)

3806 (with syringe)

3807

3805

3800

Description

  • 30 ml syringe
  • Three way stop cock
  • PVC tube (with two clamps and two Threaded Lock Cannula)
  • External injection septum
  • 10 ml syringe
  • Two way stop cock
  • PVC tube (with two clamps and pigtail ends)
  • 45 cm PVC tube (with spike, spike cover, pinch clamp and sealed end)
  • 15 cm tube (with two Male Luer Ports and adapters for Female Luer Ports
  • PVC tube (with two Male Luer Ports on either side, one clamp and two BD Threaded Lock Cannulas)
  • External injection septum

Application

Connection of VueLife® bag and  medium bag (via Baxter Interlink Injection Site)

Filling of KryoSure® 6-F (via sterile docking)

Removal of liquid from
KryoSure® 20-F, 60-F, 120-F, 180-F, and 750-C1 bags
(via exit spike port)

 Media or Suspension transfer via gravity flow

Sterile medium transfer from a medium bag to a VueLife® bag

Connection to VueLife® bag via BD Interlink Injection Site
(septum reduces risk of contamination)

Picture

         

 

Regulatory Support

We offer the following to assist you with your regulatory approval process:

  • Comprehensive documentation (e.g. Technical and Regulatory Information Overview (RIO)
  • cGMP declaration and cGMP and compliance to 21CFR8201 on Certificates of Conformance
  • Separate Certificate of Sterilization for each lot
  • Change notifications prior to relevant changes

Customized solutions can be provided to meet special compliance needs.

Please contact our Regulatory Support Team for all your regulatory requests & questions:

Phone:     +49 761 88 88 9 – 0
Email:       regulatorysupport@cellgenix.com    

 

Regulatory Resources


121CFR820: Quality System Regulations for Medical Devices of the Code of Federal Regulations of the United States

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