SC+ Haemodialysis System

GUDID 05060497260023

SC+ Dialysate Cartridge

QUANTA DIALYSIS TECHNOLOGIES LIMITED

Haemodialysis system dialysate delivery set

• Primary Device ID: 05060497260023
• NIH Device Record Key: ebb882b7-930e-49a1-8c20-b20ffdd71b2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SC+ Haemodialysis System
• Version Model Number: SC-14354
• Company DUNS: 211298693
• Company Name: QUANTA DIALYSIS TECHNOLOGIES LIMITED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060497260023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193670

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-29
• Device Publish Date: 2021-06-21

On-Brand Devices [SC+ Haemodialysis System]

• 05060497260092: SC+ Haemodialysis Delivery Device
• 05060497260030: SC+ Blood Tubeset
• 05060497260023: SC+ Dialysate Cartridge
• 05060497260016: SC+ Blood Tube Set