ReFlow Ventricular System

GUDID 00860024001816

Ventricular Catheter and Flusher

ANUNCIA, INC.

Ventriculo-peritoneal/atrial shunt

• Primary Device ID: 00860024001816
• NIH Device Record Key: a57e96b9-f850-410f-97e0-5104ef24507d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReFlow Ventricular System
• Version Model Number: A0011
• Company DUNS: 081149501
• Company Name: ANUNCIA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860024001809 [Primary]
GS1	00860024001816 [Package]; Contains: 00860024001809; Package: Overshipper [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172006

FDA Product Code

• JXG: Shunt, Central Nervous System And Components

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-02
• Device Publish Date: 2018-10-02