ECG Cable for CM 3000 Series 2014606-185

GUDID 04250903201219

The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to

getemed Medizin- und Informationstechnik AG

Electrocardiographic lead set, reusable

• Primary Device ID: 04250903201219
• NIH Device Record Key: a68e7203-f3cf-4b99-a696-17edc564edeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG Cable for CM 3000 Series
• Version Model Number: 5 Leads, 120 cm (90/30 cm), Colors: Red, Brown, Bl
• Catalog Number: 2014606-185
• Company DUNS: 331682898
• Company Name: getemed Medizin- und Informationstechnik AG
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49332939420
• Email: info@getemed.de

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250903201219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022540

FDA Product Code

• DSH: Recorder, Magnetic Tape, Medical

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: 2016-09-21

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