Pulse Pro Recovery Package 40201

GUDID 00817369021146

Pulse Pro Recovery Package - Tall

NORMATEC INDUSTRIES LP

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

• Primary Device ID: 00817369021146
• NIH Device Record Key: eb826b9d-a690-46da-9f83-3971bec39a63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse Pro Recovery Package
• Version Model Number: Pulse Pro Recovery Package - Tall
• Catalog Number: 40201
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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	00817369021146 [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

On-Brand Devices [Pulse Pro Recovery Package]

• 00817369021184: Pulse Pro Recovery Package - Power Tall
• 00817369021177: Pulse Pro Recovery Package - Power Standard
• 00817369021160: Pulse Pro Recovery Package - Power Short
• 00817369021153: Pulse Pro Recovery Package - Short
• 00817369021146: Pulse Pro Recovery Package - Tall
• 00817369021139: Pulse Pro Recovery Package - Standard