Homechoice Claria Automated Peritoneal Dialysis Cycler

Homechoice Claria Automated Peritoneal Dialysis Cycler
Homechoice Claria - 5C6M40

An assembly of devices consisting of functional units [e.g., a mains electricity (AC-powered) pump, solution mixer, monitor] intended to perform peritoneal dialysis, a treatment that removes fluid and metabolic wastes from the blood by infusing dialysate into the peritoneal cavity through a catheter and a disposable tubing system, and then removing the dialysate. Diffusion of metabolic wastes from the blood to the dialysate occurs within the abdominal cavity through the pores and intercellular channels of the peritoneum. The device may automatically control the flow of dialysate into and out of the abdominal cavity.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FKX

Device Name: System, Peritoneal, Automatic Delivery

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: 876.5630

Third Party Flag: N

Medical Specialty: GU

Device Id: 50085412676468

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00085412676463

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 00085412676463

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