ELI 280

GUDID 00812345026283

Electrocardiograph

MORTARA INSTRUMENT, INC.

Electrocardiograph, professional, multichannel

• Primary Device ID: 00812345026283
• NIH Device Record Key: b294cd4d-2f44-4cad-a4c9-de7e8e689866
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELI 280
• Version Model Number: ELI280-AAA-AAFBX
• Company DUNS: 062046149
• Company Name: MORTARA INSTRUMENT, INC.
• 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

Customer Support Contacts

• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812345026283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122073

FDA Product Code

• DPS: Electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-06-29
• Device Publish Date: 2016-09-24

On-Brand Devices [ELI 280]

• 00812345026412: Electrocardiograph
• 00812345026405: Electrocardiograph
• 00812345026399: Electrocardiograph
• 00812345026382: Electrocardiograph
• 00812345026375: Electrocardiograph
• 00812345026306: Electrocardiograph
• 00812345026290: Electrocardiograph
• 00812345026283: Electrocardiograph
• 00812345026276: Electrocardiograph
• 00812345026269: Electrocardiograph
• 00812345026252: Electrocardiograph
• 00812345026245: Electrocardiograph
• 00812345026238: Electrocardiograph
• 00812345026221: Electrocardiograph
• 00812345026214: Electrocardiograph
• 00812345026207: Electrocardiograph
• 00812345026191: Electrocardiograph
• 00812345026184: Electrocardiograph
• 00812345026177: Electrocardiograph
• 00812345026160: Electrocardiograph
• 00812345025194: Electrocardiograph
• 00812345025170: Electrocardiograph
• 00812345025156: Electrocardiograph
• 00812345025132: Electrocardiograph
• 00812345025118: Electrocardiograph
• 00812345025095: Electrocardiograph
• 00812345024975: Electrocardiograph
• 00812345024951: Electrocardiograph
• 00812345024937: Electrocardiograph
• 00812345024913: Electrocardiograph
• 00812345024890: Electrocardiograph
• 00812345024876: BUR280-81D
• 00817655022789: Electrocardiograph
• 00817655022581: Electrocardiograph
• 00817655022116: Electrocardiograph
• 00817655021966: Electrocardiograph
• 00817655021850: Electrocardiograph
• 00817655021782: Electrocardiograph
• 00817655020709: Electrocardiograph
• 00817655020624: Electrocardiograph
• 00817655020037: Electrocardiograph