RescueNet 12-Lead

GUDID 00847946021870

Stand alone software used by EMS and Hospitals to collect, distribute, and view 12-Leads to aid in rapid patient treatment for acute STEMI.

Zoll Medical Corporation

Electrocardiography telemetric monitoring system

• Primary Device ID: 00847946021870
• NIH Device Record Key: 4e4ddef6-37a7-4538-b6b2-8a688c4e7fc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RescueNet 12-Lead
• Version Model Number: 8700-010001-01
• Company DUNS: 055363428
• Company Name: Zoll Medical Corporation
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946021870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121865

FDA Product Code

• MSX: System,Network And Communication,Physiological Monitors

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-17

On-Brand Devices [RescueNet 12-Lead]

• 00847946021870: Stand alone software used by EMS and Hospitals to collect, distribute, and view 12-Leads to aid
• 00847946021863: Stand alone software used by EMS and Hospitals to collect, distribute, and view 12-Leads to aid