ELI 150c

GUDID 00812345025613

Electrocardiograph

MORTARA INSTRUMENT, INC.

Electrocardiograph, professional, multichannel

• Primary Device ID: 00812345025613
• NIH Device Record Key: cd4d379f-8b15-4e2f-bf78-db23c0a49759
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELI 150c
• Version Model Number: ELI150c-GAA-AFHAB
• 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	00812345025613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101115

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

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• 00812345025699: Electrocardiograph
• 00812345025675: Electrocardiograph
• 00812345025651: Electrocardiograph
• 00812345025637: Electrocardiograph
• 00812345025613: Electrocardiograph
• 00812345025477: Electrocardiograph
• 00812345025453: Electrocardiograph
• 00812345025439: Electrocardiograph
• 00812345025415: Electrocardiograph
• 00812345025408: Electrocardiograph
• 00812345025392: Electrocardiograph
• 00812345025378: Electrocardiograph
• 00812345025354: Electrocardiograph
• 00812345025330: Electrocardiograph
• 00812345025316: Electrocardiograph
• 00812345025293: Electrocardiograph
• 00812345025088: Electrocardiograph
• 00812345025071: Electrocardiograph
• 00812345025019: Electrocardiograph
• 00817655023144: Electrocardiograph
• 00817655023007: Electrocardiograph
• 00817655022994: Electrocardiograph
• 00817655022987: Electrocardiograph
• 00817655022659: Electrocardiograph
• 00817655022123: Electrocardiograph
• 00817655021867: Electrocardiograph
• 00817655021843: Electrocardiograph
• 00817655021805: Electrocardiograph
• 00817655021768: Electrocardiograph
• 00817655021751: Electrocardiograph
• 00817655021393: Electrocardiograph
• 00817655021317: Electrocardiograph
• 00817655020921: Electrocardiograph
• 00817655020747: Electrocardiograph
• 00817655020631: Electrocardiograph
• 00817655020464: Electrocardiograph
• 00817655020402: Electrocardiograph
• 00817655020341: Electrocardiograph
• 00817655020327: Electrocardiograph
• 00817655020211: Electrocardiograph