Pulse Pro Quick Start Guide 57003

GUDID 00817369021924

Pulse Pro Quick Start Guide

NORMATEC INDUSTRIES LP

Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system

• Primary Device ID: 00817369021924
• NIH Device Record Key: 7ee11d10-c1b6-4508-8b6a-d0487970f724
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse Pro Quick Start Guide
• Version Model Number: Pulse Pro Quick Start Guide
• Catalog Number: 57003
• Company DUNS: 111448069
• Company Name: NORMATEC INDUSTRIES LP
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817369021924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160608

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-13

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