ComfortPress Hand-Held Vascular Compression Assist Device

Basic Information

• Brand Name: ComfortPress Hand-Held Vascular Compression Assist Device
• Primary DI: 10815614020040
• Version / Model: 3100-15
• Catalog Number: 130-0100-15
• Company Name: SEMLER TECHNOLOGIES, INC.
• Labeler DUNS: 042075700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: e20e6bfb-77b9-46d3-8305-e67cbb9e14f4

Device Description

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 3100-15 is a small sterile molded handle fitted with a Jumbo SuperComfort™ Disc in a sealed package. This is a single use device.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47927	Femoral artery compression system, manual, single-use	A noninvasive, non-powered device intended to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization, typically as an alternative to direct hand pressure; it may in addition be used on brachial and radial arteries or after venipuncture. The compressing portion could be one of a variety of designs (e.g., disc affixed to a handle, ball, dome or roller, manually-inflatable bulb) and is typically held in place with a frame, bandage, or straps secured around the patient's hips/thigh. It may be used in conjunction with dressings/haemostatic agents (not included). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815614020040	GS1
Package	20815614020047	GS1	Case	20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K072167	000