CloudHRV™ System 10001001

GUDID G697100010010

Inmedix, Inc.

Electrocardiograph, professional, multichannel

• Primary Device ID: G697100010010
• NIH Device Record Key: 3da47c58-a115-4505-8389-7139b96706d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CloudHRV™ System
• Version Model Number: 10001001
• Catalog Number: 10001001
• Company DUNS: 117788373
• Company Name: Inmedix, 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: 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
HIBCC	G697100010010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241217

FDA Product Code

• DPS: Electrocardiograph

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: 2026-02-09
• Device Publish Date: 2026-01-30

On-Brand Devices [CloudHRV™ System]

• G697684810: 68481
• G697100010010: 10001001