COR12

GUDID 04251341900115

CORSCIENCE GmbH & Co. KG

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: 04251341900115
• NIH Device Record Key: 89ba1853-f553-4a7e-9dc7-4bd21adcb085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COR12
• Version Model Number: CS10785-02
• Company DUNS: 333427776
• Company Name: CORSCIENCE GmbH & Co. KG
• 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: 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	04251341900115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183369

FDA Product Code

• DPS: Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-25
• Device Publish Date: 2019-01-25

On-Brand Devices [COR12]

• 04251341900115: CS10785-02
• 04251341900108: CS10785-01
• 04251341900344: CS10785-14
• 04251341900252: CS10785-09