McKesson Cardiology ECG Management

GUDID 80010939040028

MCKESSON TECHNOLOGIES INC.

Cardiac mapping system computer

• Primary Device ID: 80010939040028
• NIH Device Record Key: eb0b7f7d-fa02-4fbd-b070-54150271d46b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: McKesson Cardiology ECG Management
• Version Model Number: 14.0
• Company DUNS: 962049362
• Company Name: MCKESSON TECHNOLOGIES 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: 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	80010939040028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113515

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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: 2017-03-09

On-Brand Devices [McKesson Cardiology ECG Management]

• 80010939040028: 14.0
• 80010939040011: 13.2.1