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PressureMate Compression Assist Device

FDA UDI

Class II (US FDA UDI)

by Semler Technologies, Inc.

Identity

Trade Name
PressureMate Compression Assist Device FDA UDI
Generic Name
Femoral artery compression system, manual, reusable FDA UDI
Device Name
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. FDA UDI
Model / Reference
3201 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
130-0201-00 FDA UDI
Primary DI / UDI-DI
10815614020064 FDA UDI
510(k) Number
K090286 FDA UDI
FDA Product Code
DXC FDA UDI
GMDN Term
Femoral artery compression system, manual, reusable 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Femoral artery compression system, manual, reusable

PressureMate 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, reusable.

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 ef63ab83-fecc-475a-b6a0-4894376fbe48 35 fields · synced May 30, 2026