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CompressAR XTS Stand

FDA UDI

Class II (US FDA UDI)

by Semler Technologies, Inc.

Identity

Trade Name
CompressAR XTS Stand FDA UDI
Generic Name
Femoral artery compression system, manual, reusable FDA UDI
Device Name
The CompressAR XTS Stand is used with CompressAR Discs, to provide hemostasis of the femoral vascular access site following femoral artery catheterization procedures. FDA UDI
Model / Reference
5000 FDA UDI
Description
The CompressAR XTS Stand is used with CompressAR Discs, to provide hemostasis of the femoral vascular access site following femoral artery catheterization procedures. FDA UDI

Identifiers

Catalog Number
150-0009-02 FDA UDI
Primary DI / UDI-DI
10815614020286 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Femoral artery compression system, manual, reusable

CompressAR XTS Stand 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 47ea8373-9e22-450e-b4b4-ad67a5da2291 34 fields · synced May 30, 2026