Hemodialyzer, Re-use, Low Flux

Device Code: 2007

Product Code(s): MSE

Device Classification Information

• Device Type ID: 2007
• Device Name: Hemodialyzer, Re-use, Low Flux
• Regulation Description: Hemodialysis System And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Renal Devices Branch (RNDB)
• Submission Type: 510(k)
• CFR Regulation Number: 876.5820 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MSE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2007
• Device: Hemodialyzer, Re-use, Low Flux
• Product Code: MSE
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hemodialysis System And Accessories.
• CFR Regulation Number: 876.5820 [🔎]

Device Problems
Fluid Leak	5
Total Device Problems	5

TPLC Last Update: 2019-04-02 20:03:58