ZOLL Arrhythmia Management System 10A1112

GUDID 00855778005463

ZOLL MANUFACTURING CORPORATION

General-purpose multi-parameter bedside monitor

• Primary Device ID: 00855778005463
• NIH Device Record Key: 1bf0583c-66ac-4385-95d5-d9768dddfdb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOLL Arrhythmia Management System
• Version Model Number: Gateway (4G)
• Catalog Number: 10A1112
• Company DUNS: 079320559
• Company Name: ZOLL MANUFACTURING CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855778005463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190939

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia

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: 2023-06-30
• Device Publish Date: 2023-06-22

On-Brand Devices [ZOLL Arrhythmia Management System]

• 00855778005364: Gateway
• 00855778005357: Sensor
• 00855778005463: Gateway (4G)