uCor Heart Failure and Arrhythmia Management System 10A1073

GUDID 00855778005326

ZOLL MANUFACTURING CORPORATION

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 00855778005326
• NIH Device Record Key: 2d37d198-b770-43ea-870c-dff8e2ee3513
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uCor Heart Failure and Arrhythmia Management System
• Version Model Number: Gateway
• Catalog Number: 10A1073
• 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	00855778005326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172510

FDA Product Code

• DSB: Plethysmograph, Impedance

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-05-17

On-Brand Devices [uCor Heart Failure and Arrhythmia Management System]

• 00855778005326: Gateway
• 00855778005302: Sensor
• 00855778005456: Gateway (4G)