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ACIST CVi®1 Contrast Delivery System Injector Head

FDA UDI

Class II (US FDA UDI)

by ACIST Medical Systems, Inc.

Identity

Trade Name
ACIST CVi®1 Contrast Delivery System Injector Head FDA UDI
Generic Name
Angiography contrast medium injection system, line-powered, mobile FDA UDI
Device Name
CVi1 Injector, p/n 700706-011 FDA UDI
Model / Reference
016670 FDA UDI
Description
CVi1 Injector, p/n 700706-011 FDA UDI

Identifiers

Primary DI / UDI-DI
10841716102193 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

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

Yes

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
MRI Safety
MR Unsafe FDA UDI

ACIST CVi®1 Contrast Delivery System Injector Head 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:

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 b5f98586-a38d-4163-a262-eea69bd73335 35 fields · synced Jun 8, 2026