MAC 8855002-001

GUDID 00195278276124

MAC 5 A5

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel

• Primary Device ID: 00195278276124
• NIH Device Record Key: ef48361d-83e6-4aca-8a2b-0666bace5d99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAC
• Version Model Number: 5 A5
• Catalog Number: 8855002-001
• Company DUNS: 006580799
• Company Name: GE MEDICAL SYSTEMS INFORMATION 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: false
• Serial Number: true
• 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	00195278276124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221321

FDA Product Code

• DQK: Computer, diagnostic, programmable

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: 2022-11-17
• Device Publish Date: 2022-11-09

On-Brand Devices [MAC]

• 00840682134859: 600
• 00840682125499: VU360
• 00840682123112: 5500 HD REMAN
• 00840682106481: 800
• 00840682105071: 2000
• 00840682104838: 5500 HD
• 00840682104791: 3500
• 00195278276124: MAC 5 A5
• 00195278276087: MAC 5 Lite
• 00195278276070: MAC 5 A4