Imaging System Interface - ISI2 Module
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ISI2 EUDAMEDImaging System Interface - ISI2 Module FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- ISI2 Module EUDAMEDASSY, Module, ISI2 (86882302) FDA UDIASSY,MODULE,ISI2,CORE (89302900) FDA UDI
- Model / Reference
- ISI2 EUDAMEDFDA UDI
- Description
- ASSY, Module, ISI2 (86882302) FDA UDIASSY,MODULE,ISI2,CORE (89302900) FDA UDI
Identifiers
- Catalog Number
- ISI2 FDA UDI
- Primary DI / UDI-DI
- 00616258022512 EUDAMEDFDA UDI00616258027340 EUDAMEDFDA UDI
- Basic UDI-DI
- 0616258TFCN-0104Q3 EUDAMED
- 510(k) Number
- K182273 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- Z119099 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- CT contrast medium injection system, line-powered, mobile FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: CT contrast medium injection system, line-powered, mobile
Imaging System Interface - ISI2 Module by Bayer Medical Care Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K182273 also covers:
- Low Pressure Connector Tubing Integral “T” with Check Valve — Bayer Medical Care Inc.
- MEDRAD® Stellant Heat Maintainer — Bayer Medical Care Inc.
- MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube — Bayer Medical Care Inc.
- MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube — Bayer Medical Care Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bayer Medical Care Inc.
Sources (4)
- FDA UDI 3370ca6d-f851-4576-ab28-e6833b254157 38 fields · synced Jul 21, 2026
- FDA UDI 1bf7e19a-69dc-48df-accd-e8a2fec7e5c8 38 fields · synced May 30, 2026
- EUDAMED 92ee48f9-9c38-4cd3-b7e8-89443ad94bfe 61 fields · synced Jul 17, 2026
- EUDAMED 3e7442b2-2ba1-4291-82c7-30ea2e909812 61 fields · synced Jul 21, 2026