ELI 380

GUDID 00812345026719

Electrocardiograph

MORTARA INSTRUMENT, INC.

Electrocardiograph, professional, multichannel

• Primary Device ID: 00812345026719
• NIH Device Record Key: 4fe0a672-cbcd-4c92-be1e-ce6164febe13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELI 380
• Version Model Number: ELI380-DAS4X
• 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	00812345026719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142105

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 380 ]

• 00812345027020: Electrocardiograph
• 00812345027013: Electrocardiograph
• 00812345027006: Electrocardiograph
• 00812345026993: Electrocardiograph
• 00812345026986: Electrocardiograph
• 00812345026979: Electrocardiograph
• 00812345026962: Electrocardiograph
• 00812345026955: Electrocardiograph
• 00812345026948: Electrocardiograph
• 00812345026931: Electrocardiograph
• 00812345026924: Electrocardiograph
• 00812345026917: Electrocardiograph
• 00812345026900: Electrocardiograph
• 00812345026894: Electrocardiograph
• 00812345026887: Electrocardiograph
• 00812345026870: Electrocardiograph
• 00812345026863: Electrocardiograph
• 00812345026856: Electrocardiograph
• 00812345026849: Electrocardiograph
• 00812345026832: Electrocardiograph
• 00812345026825: Electrocardiograph
• 00812345026818: Electrocardiograph
• 00812345026801: Electrocardiograph
• 00812345026795: Electrocardiograph
• 00812345026788: Electrocardiograph
• 00812345026771: Electrocardiograph
• 00812345026764: Electrocardiograph
• 00812345026757: Electrocardiograph
• 00812345026740: Electrocardiograph
• 00812345026733: Electrocardiograph
• 00812345026726: Electrocardiograph
• 00812345026719: Electrocardiograph
• 00812345026702: Electrocardiograph
• 00812345026696: Electrocardiograph
• 00812345026689: Electrocardiograph
• 00812345026672: Electrocardiograph
• 00812345026665: Electrocardiograph
• 00812345026658: Electrocardiograph
• 00812345026641: Electrocardiograph
• 00812345026634: Electrocardiograph
• 00812345026627: Electrocardiograph
• 00812345026610: Electrocardiograph
• 00812345026603: Electrocardiograph
• 00812345026597: Electrocardiograph
• 00812345026580: Electrocardiograph
• 00812345026573: Electrocardiograph
• 00812345026566: Electrocardiograph
• 00812345026559: Electrocardiograph
• 00812345026542: Electrocardiograph
• 00812345026535: Electrocardiograph