MAC 8855001-001

GUDID 00195278276070

MAC 5 A4

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Electrocardiograph, professional, multichannel

• Primary Device ID: 00195278276070
• NIH Device Record Key: 633a797b-b09d-4a02-be5f-510d281a6683
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAC
• Version Model Number: 5 A4
• Catalog Number: 8855001-001
• 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	00195278276070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221321

FDA Product Code

• DXH: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

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