Quanta Dialysis System

GUDID 15060497260167

Quanta Dialysis System Hemodialysis Delivery Device

QUANTA DIALYSIS TECHNOLOGIES LIMITED

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• Primary Device ID: 15060497260167
• NIH Device Record Key: 0001bf37-79eb-488d-8a6a-109540bf6601
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quanta Dialysis System
• Version Model Number: SC-13940
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	15060497260167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222067

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: 2023-07-11
• Device Publish Date: 2023-07-03

On-Brand Devices [Quanta Dialysis System]

• 15060497260167: Quanta Dialysis System Hemodialysis Delivery Device
• 05060497260160: Quanta Dialysis System Hemodialysis Delivery Device