PC ECG

GUDID 06944413800533

Edan Instruments, Inc.

Electrocardiograph, professional, multichannel

• Primary Device ID: 06944413800533
• NIH Device Record Key: 51480a1f-d450-4dfb-808b-2af8f0b223df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PC ECG
• Version Model Number: SE-1010
• Company DUNS: 529173163
• Company Name: Edan Instruments, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413800533 [Primary]
GS1	6944413807174 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131819

FDA Product Code

• DPS: Electrocardiograph

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: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [PC ECG]

• 06944413807778: ECG-1212
• 06944413806948: ECG-1212/ST
• 06944413802759: PADECG
• 06944413802049: SE-1515
• 06944413800533: SE-1010