ZOLL Code Writer

GUDID 00847946021894

Stand alone software that provides a reliable and consistent method for Advanced Cardiac Life Support (ACLS) caregivers to electronically record observations and care interventions during cardiac resuscitation events and allow users to view, edit and integrate that data into their medical record systems.

Zoll Medical Corporation

Medical equipment clinical data interfacing software

• Primary Device ID: 00847946021894
• NIH Device Record Key: 4bbabdfb-2592-4c6d-8f07-c4bb2140a67b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOLL Code Writer
• Version Model Number: 9658-0304-01
• 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	00847946021894 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132488

FDA Product Code

• NSX: Software, Transmission And Storage, Patient Data

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2017-03-17

On-Brand Devices [ZOLL Code Writer ]

• 00847946021894: Stand alone software that provides a reliable and consistent method for Advanced Cardiac Life Su
• 00847946021887: Stand alone software that provides a reliable and consistent method for Advanced Cardiac Life Su