WAVE Clinical Platform

GUDID 00856128007007

The WAVE Clinical Platform software displays, routes, and stores medical device and diagnostic information from supported devices.

EXCEL MEDICAL ELECTRONICS LLC

Medical equipment clinical data interfacing software

• Primary Device ID: 00856128007007
• NIH Device Record Key: 2db7d593-7603-4978-8f06-2e598421cace
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVE Clinical Platform
• Version Model Number: NG
• Company DUNS: 079605674
• Company Name: EXCEL MEDICAL ELECTRONICS LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856128007007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171056

FDA Product Code

• MWI: Monitor,Physiological,Patient(Without 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: 2018-11-08
• Device Publish Date: 2018-01-29