NuVision ICE Catheter

GUDID 00860005688104

The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use.

Nuvera Medical, Inc.

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• Primary Device ID: 00860005688104
• NIH Device Record Key: 446dfa6b-d5e0-4789-8b7f-3d77ae49b535
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuVision ICE Catheter
• Version Model Number: FG10593
• Company DUNS: 117379819
• Company Name: Nuvera Medical, Inc.
• 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: true
• 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	00860005688104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201775

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

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: 2021-07-15
• Device Publish Date: 2021-07-07

Devices Manufactured by Nuvera Medical, Inc.

• 00860005688104 - NuVision ICE Catheter: 2021-07-15The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use.
• 00860005688104 - NuVision ICE Catheter: 2021-07-15 The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use.
• 00860005688111 - NuVision Connector Cable: 2021-07-15 The NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision IC