← Back to catalogue

CVi® Cable

FDA UDI

Class II (US FDA UDI)

by ACIST Medical Systems, Inc.

Identity

Trade Name
CVi® Cable FDA UDI
Generic Name
Angiography contrast medium injection system, line-powered, mobile FDA UDI
Device Name
CVi Medex Spacelabs cable, p/n 300501-001 FDA UDI
Model / Reference
015636 FDA UDI
Description
CVi Medex Spacelabs cable, p/n 300501-001 FDA UDI

Identifiers

Primary DI / UDI-DI
30841716102036 FDA UDI
510(k) Number
K171646 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

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K171646 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ACIST Medical Systems, Inc.

Sources (1)

  • FDA UDI 0dfbedf2-99f4-452c-b0f8-7dc161af3470 35 fields · synced Jun 8, 2026