ComfortPress Hand-Held Vascular Compression Assist Device 130-0100-13

GUDID 20815614020030

The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device. ComfortPress is designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure using ComfortPress in much the same way that they would when applying manual pressure. The Model 3100-13 is a small sterile molded handle fitted with a Large SuperComfort™ Disc in a sealed package. This is a single use device.

Semler Technologies, Inc.

Femoral artery compression system, manual, single-use

• Primary Device ID: 20815614020030
• NIH Device Record Key: 5330c485-36bc-4e70-864d-c60e83b2cd2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComfortPress Hand-Held Vascular Compression Assist Device
• Version Model Number: 3100-13
• Catalog Number: 130-0100-13
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	10815614020033 [Primary]
GS1	20815614020030 [Package]; Contains: 10815614020033; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072167

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2024-10-16
• Device Publish Date: 2016-09-24

On-Brand Devices [ComfortPress Hand-Held Vascular Compression Assist Device]

• 10815614020040: The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposab
• 20815614020030: The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposab
• 10815614020026: The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposab
• 10815614020019: The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposab