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ACIST RXi® System with dPR

FDA UDI

Class II (US FDA UDI)

by ACIST Medical Systems, Inc.

Identity

Trade Name
ACIST RXi® System with dPR FDA UDI
Generic Name
Cardiac catheterization laboratory computer FDA UDI
Device Name
RXi System with dPR, US (p/n: 800981-010 ) FDA UDI
Model / Reference
019995 FDA UDI
Description
RXi System with dPR, US (p/n: 800981-010 ) FDA UDI

Identifiers

Primary DI / UDI-DI
40841716103757 FDA UDI
510(k) Number
K233904 FDA UDI
FDA Product Code
DXO FDA UDI
GMDN Term
Cardiac catheterization laboratory computer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2870 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: Cardiac catheterization laboratory computer

ACIST RXi® System with dPR by ACIST Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac catheterization laboratory computer.

Cleared under the same submission

K233904 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ACIST Medical Systems, Inc.

Sources (1)

  • FDA UDI 567c216e-f016-41e8-9e76-5869da6bb41c 34 fields · synced Jun 8, 2026