PC ECG

GUDID 06944413800533

Edan Instruments, Inc.

Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel 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