ComfortPress Hand-Held Vascular Compression Assist Device 130-0100-15

GUDID 10815614020040

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.

Semler Technologies, Inc.

Femoral artery compression system, manual, single-use
Primary Device ID10815614020040
NIH Device Record Keye20e6bfb-77b9-46d3-8305-e67cbb9e14f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfortPress Hand-Held Vascular Compression Assist Device
Version Model Number3100-15
Catalog Number130-0100-15
Company DUNS042075700
Company NameSemler Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110815614020040 [Primary]
GS120815614020047 [Package]
Package: Case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCClamp, Vascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2024-10-16
Device Publish Date2016-09-24

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

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

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