WAM

GUDID 00817655022062

Wireless Acquisition System cleared with the ELI 230 Electrocardiograph

MORTARA INSTRUMENT, INC.

Electrocardiographic lead set, reusable

• Primary Device ID: 00817655022062
• NIH Device Record Key: 6daca21e-d712-46b3-bea4-a0beb345a9fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAM
• Version Model Number: 41000-031-54
• 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
• 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 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817655022062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100127

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: 4
• Public Version Date: 2020-06-29
• Device Publish Date: 2017-09-19

On-Brand Devices [WAM]

• 00812345029758: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00812345029741: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00812345029734: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00812345029727: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00812345021752: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00812345021745: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655022741: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655022079: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655022062: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655022031: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655021959: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655020549: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655020532: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655020525: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655020518: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655020471: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655020273: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655020266: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655020150: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph
• 00817655020099: Wireless Acquisition System cleared with the ELI 230 Electrocardiograph