SEER 1000 ECG Cable 2067634-014

GUDID 04250903200762

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: 04250903200762
• NIH Device Record Key: 3b0da713-d605-44dd-aba5-955561549382
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEER 1000 ECG Cable
• Version Model Number: 7 Leads (3 Channels), 61 cm (24 in), IEC Color Cod
• Catalog Number: 2067634-014
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250903200762 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [SEER 1000 ECG Cable]

• 04250903200861: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903200854: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903200847: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903200830: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903200823: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903200816: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903200809: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903200793: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903200786: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903200779: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903200762: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
• 04250903200755: The cable is intended to be used to conduct electrical signals from a patient's heart, via an el