CAPIOX® HEMOCONCENTRATOR

CAPIOX® HEMOCONCENTRATOR - CX*HC11L

A sterile filter intended to be used in the process of haemoconcentration (the concentration of blood elements by water and electrolyte removal) typically during treatment for fluid overload or during cardiac surgery involving extracorporeal circulation. It is typically an ultrafiltration filter contained within a closed cylindrical housing with connectors to an extracorporeal blood circuit and separate connectors for the removal of excess plasma water together with small plasma solutes (e.g., smaller than 50,000 Daltons); the haemoconcentrate is returned to the patient. This is a single-use device.

• Area/Surface Area: 1.1 Square meter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KDI

Device Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.5860

Third Party Flag: N

Medical Specialty: GU

Device Id: 54987350738412

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04987350738417

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 04987350738417

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A