ELI 250c

GUDID 00817655020501

Electrocardiograph

MORTARA INSTRUMENT, INC.

Electrocardiograph, professional, multichannel

• Primary Device ID: 00817655020501
• NIH Device Record Key: bd7c9783-e408-4572-aef7-5b6a9710ae11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELI 250c
• Version Model Number: ELI250c-MAA-AAFBB
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817655020501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101403

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: 2016-11-07

On-Brand Devices [ELI 250c]

• 00812345029963: Electrocardiograph
• 00812345026368: Electrocardiograph
• 00812345026153: Electrocardiograph
• 00812345026146: Electrocardiograph
• 00812345026139: Electrocardiograph
• 00812345026122: Electrocardiograph
• 00812345026115: Electrocardiograph
• 00812345026108: Electrocardiograph
• 00812345026092: Electrocardiograph
• 00812345026085: Electrocardiograph
• 00812345026078: Electrocardiograph
• 00812345026061: Electrocardiograph
• 00812345026054: Electrocardiograph
• 00812345026047: Electrocardiograph
• 00812345026030: Electrocardiograph
• 00812345026016: Electrocardiograph
• 00812345025828: Electrocardiograph
• 00812345025811: Electrocardiograph
• 00812345024869: Electrocardiograph
• 00812345024852: Electrocardiograph
• 00812345024760: Electrocardiograph
• 00812345024753: BUR250c-81X
• 00812345024463: Electrocardiograph
• 00817655023212: Electrocardiograph
• 00817655023168: Electrocardiograph
• 00817655023083: Electrocardiograph
• 00817655023014: Electrocardiograph
• 00817655022963: Electrocardiograph
• 00817655022871: Electrocardiograph
• 00817655022864: Electrocardiograph
• 00817655022758: Electrocardiograph
• 00817655022574: Electrocardiograph
• 00817655021973: Electrocardiograph
• 00817655021799: Electrocardiograph
• 00817655021645: Electrocardiograph
• 00817655021478: Electrocardiograph
• 00817655021416: Electrocardiograph
• 00817655021409: Electrocardiograph
• 00817655021386: Electrocardiograph
• 00817655021324: Electrocardiograph
• 00817655021300: Electrocardiograph
• 00817655020938: Electrocardiograph
• 00817655020778: Electrocardiograph
• 00817655020761: Electrocardiograph
• 00817655020662: Electrocardiograph
• 00817655020501: Electrocardiograph
• 00817655020419: Electrocardiograph
• 00817655020358: Electrocardiograph
• 00817655020235: Electrocardiograph
• 00817655020020: Electrocardiograph