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ACIST RXi® System and Accessories

FDA UDI

Class II (US FDA UDI)

by ACIST Medical Systems, Inc.

Identity

Trade Name
ACIST RXi® System and Accessories FDA UDI
Generic Name
Cardiac catheterization laboratory computer FDA UDI
Device Name
RXi System Overpack, p/n 800981-003 Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables) FDA UDI
Model / Reference
014666 FDA UDI
Description
RXi System Overpack, p/n 800981-003 Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables) FDA UDI

Identifiers

Primary DI / UDI-DI
40841716100671 FDA UDI
510(k) Number
K132474 FDA UDI
FDA Product Code
OBI FDA UDI
GMDN Term
Cardiac catheterization laboratory computer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 FDA UDI
Commercial Distribution
Not 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

Yes

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

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

Cleared under the same submission

K132474 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 6dae65ed-a378-4299-b9fd-889199487046 35 fields · synced Jun 8, 2026