Identity
- Trade Name
- MEDRAD® Stellant Heat Maintainer FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- MAINTAINER,SYR HEAT,STEL,PFS,LR (88457285) FDA UDI
- Model / Reference
- SSH 100F FDA UDI
- Description
- MAINTAINER,SYR HEAT,STEL,PFS,LR (88457285) FDA UDI
Identifiers
- Catalog Number
- SSH 100F FDA UDI
- Primary DI / UDI-DI
- 00616258026473 FDA UDI
- 510(k) Number
- K182273 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- CT 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
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
Yes
FDA UDI
Category: CT contrast medium injection system, line-powered, mobile
MEDRAD® Stellant Heat Maintainer by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as CT contrast medium injection system, line-powered, mobile.
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- Injector Mounting Arm, Left — Bracco Injeneering · Class II
- MEDRAD® Centargo CT Injection System — IMAXEON PTY LTD · Class II
- Injector — Bracco Injeneering · Class II
- Injector Mounting Arm, Right — Bracco Injeneering · Class II
Cleared under the same submission
K182273 also covers:
- Imaging System Interface - ISI2 Module — Bayer Medical Care Inc.
- Low Pressure Connector Tubing Integral “T” with Check Valve — 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 (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
- Bayer Medical Care Inc.
Sources (1)
- FDA UDI d0e8a4d5-c994-4949-9975-ef05213f5f2d 37 fields · synced Jun 9, 2026