ECG Cable for CM 3000-12 BT / SEER 12 2104809-001

GUDID 04250903201714

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 an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder).

getemed Medizin- und Informationstechnik AG

Electrocardiographic lead set, reusable

• Primary Device ID: 04250903201714
• NIH Device Record Key: 2e808543-17ea-4248-be22-77dc26b5698a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG Cable for CM 3000-12 BT / SEER 12
• Version Model Number: 10 Leads, 105 cm, IEC Color Code, Flat
• Catalog Number: 2104809-001
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250903201714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063042

FDA Product Code

• MWJ: Electrocardiograph,Ambulatory(Without Analysis)

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: 2019-09-20
• Device Publish Date: 2019-09-12

On-Brand Devices [ECG Cable for CM 3000-12 BT / SEER 12]

• 04250903201189: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201165: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201158: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201738: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201721: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201714: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201707: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el