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ComfortPress Hand-Held Vascular Compression Assist Device

FDA UDI

Class II (US FDA UDI)

by Semler Technologies, Inc.

Identity

Trade Name
ComfortPress Hand-Held Vascular Compression Assist Device FDA UDI
Generic Name
Femoral artery compression system, manual, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
3100-13 FDA UDI
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 3100-13 is a small sterile molded handle fitted with a Large SuperComfort™ Disc in a sealed package. This is a single use device. FDA UDI

Identifiers

Catalog Number
130-0100-13 FDA UDI
Primary DI / UDI-DI
10815614020033 FDA UDI
510(k) Number
K072167 FDA UDI
FDA Product Code
DXC FDA UDI
GMDN Term
Femoral artery compression system, manual, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Femoral artery compression system, manual, single-use

ComfortPress Hand-Held Vascular Compression Assist Device by Semler Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femoral artery compression system, manual, single-use.

Cleared under the same submission

K072167 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Semler Technologies, Inc.

Sources (1)

  • FDA UDI 5330c485-36bc-4e70-864d-c60e83b2cd2c 35 fields · synced Jun 1, 2026