SC+ Haemodialysis System

GUDID 05060497260016

SC+ Blood Tube Set

QUANTA DIALYSIS TECHNOLOGIES LIMITED

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• Primary Device ID: 05060497260016
• NIH Device Record Key: 2d2bc557-58b1-4f00-b002-2b7cec56c36b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SC+ Haemodialysis System
• Version Model Number: SC-14358
• Company DUNS: 211298693
• Company Name: QUANTA DIALYSIS TECHNOLOGIES LIMITED
• Device Count: 1
• DM Exempt: false
• 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	05060497260016 [Primary]

FDA Product Code

• FJK: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-04
• 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