Patient Cable Lead Set

GUDID 00812345021950

Leadwire set cleared with ELI 280

MORTARA INSTRUMENT, INC.

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable

• Primary Device ID: 00812345021950
• NIH Device Record Key: 01317408-a956-497c-b80e-bbf982186068
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Cable Lead Set
• Version Model Number: 9293-046-60
• 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 149 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812345021950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122073

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: 2016-09-24

On-Brand Devices [Patient Cable Lead Set]

• 00812345025767: Leadwire set cleared with ELI 380
• 00812345025750: Leadwire set cleared with ELI 380
• 00812345025743: Leadwire set cleared with ELI 380
• 00812345025736: Leadwire set cleared with ELI 380
• 00812345025729: Leadwire set cleared with ELI 380
• 00812345025712: Leadwire set cleared with ELI 380
• 00812345025705: Patient cable cleared with XScribe Stress System
• 00812345025682: Patient cable cleared with ELI 380
• 00812345025668: Patient cable cleared with ELI 380
• 00812345025644: Patient cable cleared with ELI 380
• 00812345025620: Patient cable cleared with ELI 380
• 00812345025606: Patient cable cleared with ELI 380
• 00812345025590: Patient cable cleared with ELI 380
• 00812345025583: Patient cable cleared with ELI 380
• 00812345025576: Patient cable cleared with ELI 380
• 00812345025569: Leadwire set cleared with ELI 280
• 00812345025552: Leadwire set cleared with ELI 280
• 00812345025545: Leadwire set cleared with ELI 280
• 00812345025538: Leadwire set cleared with ELI 280
• 00812345025521: Leadwire set cleared with ELI 280
• 00812345025514: Leadwire set cleared with ELI 280
• 00812345025507: Leadwire set cleared with ELI 280
• 00812345025491: Leadwire set cleared with ELI 280
• 00812345025484: Leadwire set cleared with ELI 280
• 00812345025460: Leadwire set cleared with ELI 280
• 00812345025446: Leadwire set cleared with ELI 280
• 00812345025422: Leadwire set cleared with ELI 280
• 00812345025347: Patient cable cleared with ELI 350
• 00812345025323: Patient cable cleared with ELI 350
• 00812345025309: Patient cable cleared with ELI 350
• 00812345025286: Patient cable cleared with ELI 350
• 00812345025248: Patient cable cleared with ELI 350
• 00812345025224: Patient cable cleared with ELI 350
• 00812345025200: Patient cable cleared with ELI 350
• 00812345025187: Patient cable cleared with ELI 350
• 00812345025163: Patient cable cleared with ELI 350
• 00812345025149: Patient cable cleared with ELI 350
• 00812345022766: Patient cable cleared with XScribe Stress System
• 00812345022025: Patient cable cleared with ELI 380
• 00812345022018: Patient cable cleared with ELI 380
• 00812345022001: Patient cable cleared with ELI 380
• 00812345021998: Patient cable cleared with ELI 380
• 00812345021981: Leadwire set cleared with ELI 280
• 00812345021974: Leadwire set cleared with ELI 280
• 00812345021967: Leadwire set cleared with ELI 280
• 00812345021950: Leadwire set cleared with ELI 280
• 00812345021943: Patient cable cleared with ELI 350
• 00812345021936: Patient cable cleared with ELI 350
• 00812345021929: Patient cable cleared with ELI 350
• 00812345021912: Patient cable cleared with ELI 350