ALGORITHM SERVICES 2104498-003

GUDID 00195278457547

ALGORITHM SERVICES EK12 V2

Ge Medical Systems Information Technologies, Inc.

Cardiology information system application software

• Primary Device ID: 00195278457547
• NIH Device Record Key: 242df7b4-af0d-4fb8-9979-54b222a88a14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALGORITHM SERVICES
• Version Model Number: EK12 V2
• Catalog Number: 2104498-003
• Company DUNS: 118935631
• 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	00195278457547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221904

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: 2
• Public Version Date: 2025-03-13
• Device Publish Date: 2023-01-10

On-Brand Devices [ALGORITHM SERVICES]

• 00840682125895: EK12
• 00195278457547: ALGORITHM SERVICES EK12 V2