ACIST CVi®1 Contrast Delivery System

FDA UDI

Class II (US FDA UDI)

by ACIST Medical Systems, Inc.

Identity

Trade Name: ACIST CVi®1 Contrast Delivery System FDA UDI
Generic Name: Angiography contrast medium injection system, line-powered, mobile FDA UDI
Device Name: CVi1 Injector p/n 801091-002 Contents: CVi Injector Head (Siemens), Bed Mount, & Power Supply FDA UDI
Model / Reference: 016613 FDA UDI
Description: CVi1 Injector p/n 801091-002 Contents: CVi Injector Head (Siemens), Bed Mount, & Power Supply FDA UDI

Identifiers

Primary DI / UDI-DI: 40841716102200 FDA UDI
510(k) Number: K191060 FDA UDI
FDA Product Code: DXT FDA UDI
GMDN Term: Angiography contrast medium injection system, line-powered, mobile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1650 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

ACIST CVi®1 Contrast Delivery System by ACIST Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K191060 also covers:

A1000V Single Use Syringe Kit — ACIST Medical Systems, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: ACIST Medical Systems, Inc.

Sources (1)

FDA UDI 353d22a6-522d-4ad9-a575-b3f07b0c3899 35 fields · synced Jun 8, 2026