Surveyor S12/S19 Patient Cable

GUDID 00812345025804

Patient cable cleared with S12/S19 Monitor

MORTARA INSTRUMENT, INC.

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable

• Primary Device ID: 00812345025804
• NIH Device Record Key: d112e8a0-bfae-4b65-bd55-9bcba029f33e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surveyor S12/S19 Patient Cable
• Version Model Number: 9293-050-61
• 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: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812345025804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123556

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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: 2016-09-24

On-Brand Devices [Surveyor S12/S19 Patient Cable]

• 00812345029925: Patient cable cleared with S12/S19 Monitor
• 00812345025804: Patient cable cleared with S12/S19 Monitor
• 00812345025781: Patient cable cleared with S12/S19 Monitor
• 00812345024043: Patient cable cleared with S12/S19 Monitor
• 00812345024036: Patient cable cleared with S12/S19 Monitor
• 00812345024005: Patient cable cleared with S12/S19 Monitor
• 00812345023886: Patient cable cleared with S12/S19 Monitor
• 00812345023688: Patient cable cleared with S12/S19 Monitor
• 00812345023671: Patient cable cleared with S12/S19 Monitor