PressureMate Compression Assist Device 130-0201-00

GUDID 10815614020064

The PressureMate Compression Assist Device is designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure with PressureMate in much the same way that they would when applying manual pressure. PressureMate is comprised of a non-sterile, reusable handle and a sterile, disposable SuperComfort Disc (Model 5303 or 5305) to aid in the practice of manual compression. The Model 3201 is of 23 oz. weighted stainless steel construction.

Semler Technologies, Inc.

Femoral artery compression system, manual, reusable

• Primary Device ID: 10815614020064
• NIH Device Record Key: ef63ab83-fecc-475a-b6a0-4894376fbe48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PressureMate Compression Assist Device
• Version Model Number: 3201
• Catalog Number: 130-0201-00
• Company DUNS: 042075700
• Company Name: Semler Technologies, Inc.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815614020064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090286

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2024-10-16
• Device Publish Date: 2016-09-24

On-Brand Devices [PressureMate Compression Assist Device]

• 10815614020057: The PressureMate Compression Assist Device is designed to enhance comfort for the practitioner a
• 10815614020064: The PressureMate Compression Assist Device is designed to enhance comfort for the practitioner a