Pulse Arm Sleeve 20201

GUDID 00817369020385

Pulse Left Arm Sleeve Black

NORMATEC INDUSTRIES LP

Sequential venous compression system Sequential venous compression system Sequential venous compression system

• Primary Device ID: 00817369020385
• NIH Device Record Key: 9471229b-3c39-4a35-8e75-c4a9c2dc155c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse Arm Sleeve
• Version Model Number: Pulse Left Arm Sleeve Black
• Catalog Number: 20201
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817369020385 [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 Arm Sleeve]

• 00817369020385: Pulse Left Arm Sleeve Black
• 00817369020378: Pulse Right Arm Sleeve Black