ApexPro

GUDID 00840682109024

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Electrocardiography telemetric monitoring system

• Primary Device ID: 00840682109024
• NIH Device Record Key: 117b18ff-8c75-4ed4-a4a1-106d6f1963d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ApexPro
• Version Model Number: FH Transceiver
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682109024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080251

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: 4
• Public Version Date: 2019-07-16
• Device Publish Date: 2016-06-10

On-Brand Devices [ApexPro]

• 00840682109024: FH Transceiver
• 00840682108928: CH Transmitter
• 00840682108799: 600 MHz Receiver