ALGORITHM SERVICES

GUDID 00840682125895

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiology information system application software

• Primary Device ID: 00840682125895
• NIH Device Record Key: 0ed249d0-5639-4156-b41a-c60170da8025
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALGORITHM SERVICES
• Version Model Number: EK12
• Company DUNS: 784985108
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682125895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170155

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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: 2017-11-01

On-Brand Devices [ALGORITHM SERVICES]

• 00840682125895: EK12
• 00195278457547: ALGORITHM SERVICES EK12 V2