Patient Monitor

GUDID 06938368100091

General Meditech. Inc.

Cardiac arrhythmia monitoring system

• Primary Device ID: 06938368100091
• NIH Device Record Key: 3a84bb75-043e-407c-b61d-41962edc9e32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Monitor
• Version Model Number: G3F
• Company DUNS: 545261786
• Company Name: General Meditech. 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938368100084 [Primary]
GS1	06938368100091 [Package]; Contains: 06938368100084; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092970

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: 2016-12-19

On-Brand Devices [Patient Monitor]

• 06938368100244: G3R
• 06938368100237: G2A
• 06938368100213: G3S
• 06938368100190: G3M
• 06938368100176: G3N
• 06938368100152: G3L
• 06938368100138: G3H
• 06938368100114: G3G
• 06938368100091: G3F
• 06938368100077: G3D
• 06938368100053: G3C