ECG Cable for SEER 1000 2104818-001

GUDID 04250903201660

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 ( SEER 1000 recorder).

getemed Medizin- und Informationstechnik AG

Electrocardiographic lead set, reusable

• Primary Device ID: 04250903201660
• NIH Device Record Key: af507b17-217b-4a45-a75e-060a6a6cdf4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG Cable for SEER 1000
• Version Model Number: 3 Leads, 75 cm, IEC Color Code
• Catalog Number: 2104818-001
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250903201660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130785

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 SEER 1000]

• 04250903201691: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201684: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201677: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201660: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201653: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201646: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201639: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201622: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201615: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201608: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201592: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903201585: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el