Blue Boot 20105

GUDID 00817369020293

5 Cell Standard Blue Boot

NORMATEC INDUSTRIES LP

Sequential venous compression system

• Primary Device ID: 00817369020293
• NIH Device Record Key: ca7f3c9f-acae-4b70-a17c-350eafd2c803
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blue Boot
• Version Model Number: 5 Cell Boot
• Catalog Number: 20105
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817369020293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013436

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: 2016-09-22

On-Brand Devices [Blue Boot]

• 00817369020361: 3 Cell Zippered Boot Blue
• 00817369020354: 4 Cell XL Boot Blue
• 00817369020347: 5 Cell XL Boot Blue
• 00817369020330: 5 Cell Extra Long Boot Blue
• 00817369020323: 4 Cell XL Zippered Blue Boot
• 00817369020316: 5 Cell XL Zippered Blue Boot
• 00817369020309: 4 Cell Standard Blue Boot
• 00817369020293: 5 Cell Standard Blue Boot
• 00817369020286: 4 Cell Custom Blue Boot (OS 1-29)
• 00817369020279: 4 Cell Custom Blue Boot (OS 1-26)
• 00817369020262: 4 Cell Custom Blue Boot (OS 1-23)
• 00817369020255: 4 Cell Standard Zippered Boot Blue
• 00817369020248: 5 Cell Standard Zippered Boot (Blue)