Identity
- Trade Name
- ACIST CVi® Contrast Delivery System FDA UDI
- Generic Name
- Angiography contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- CVi Injector p/n 800620-024 Contents: CVi Injector Head (Siemens), Control Panel, & Power Supply FDA UDI
- Model / Reference
- 014658 FDA UDI
- Description
- CVi Injector p/n 800620-024 Contents: CVi Injector Head (Siemens), Control Panel, & Power Supply FDA UDI
Identifiers
- Primary DI / UDI-DI
- 40841716101883 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
- 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
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
MR Unsafe FDA UDI
Category: Angiography contrast medium injection system, line-powered, mobile
ACIST CVi® Contrast Delivery System by ACIST Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Angiography contrast medium injection system, line-powered, mobile.
- MEDRAD® Mark 7 Arterion Injection System — Bayer Medical Care Inc. · Class II
- MEDRAD® Mark 7 Arterion Injection System — Bayer Medical Care Inc. · Class II
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care Inc. · Class II
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care Inc. · Class II
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care Inc. · Class II
- ASSY, CBL, STRT SW, AUX, 25FT, PROV, UDI, BATCH — Bayer Medical Care Inc. · Class II
- MEDRAD® Mark 7 Arterion Heat Maintainer, Syringe — Bayer Medical Care Inc. · Class II
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care Inc. · Class II
Cleared under the same submission
K171646 also covers:
- ACIST CVi® Contrast Delivery System — ACIST Medical Systems, Inc.
- ACIST CVi® Contrast Delivery System Control Panel — ACIST Medical Systems, Inc.
- ACIST CVi® Contrast Delivery System Injector Head — ACIST Medical Systems, Inc.
- ACIST CVi® Contrast Delivery System Injector Head — ACIST Medical Systems, Inc.
- ACIST CVi® Contrast Delivery System Power Supply — ACIST Medical Systems, Inc.
- AngioTouch® Kit — ACIST Medical Systems, Inc.
- AngioTouch® Kit — ACIST Medical Systems, Inc.
- BT2000 Automated Manifold 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 5cc8640d-e2d3-415f-8379-6db7e4f4eea5 34 fields · synced Jun 8, 2026