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MEDRAD® Avanta Fluid Management Injection System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MEDRAD® Avanta Fluid Management Injection System FDA UDI
- Generic Name
- Angiography contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- AVANTA,SYS,INJ,PEDESTAL MOUNT,CS,LR,4ED (87970191) FDA UDI
- Model / Reference
- AVA 500 PEDL FDA UDI
- Description
- AVANTA,SYS,INJ,PEDESTAL MOUNT,CS,LR,4ED (87970191) FDA UDI
Identifiers
- Catalog Number
- AVA 500 PEDL FDA UDI
- Primary DI / UDI-DI
- 00616258025230 FDA UDI
- 510(k) Number
- K050456 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
No
FDA UDI
Combination Product
No
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
Category: Angiography contrast medium injection system, line-powered, mobile
MEDRAD® Avanta Fluid Management Injection System by Bayer Medical Care Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K050456 also covers:
- Avanta Hand Controller Sheath — Bayer Medical Care Inc.
- Display Control Unit Sheath — Bayer Medical Care Inc.
- Display Control Unit Sheath — Bayer Medical Care Inc.
- Display Control Unit Sheath — Bayer Medical Care Inc.
- Display Control Unit Sheath — Bayer Medical Care Inc.
- Display Control Unit Sheath — Bayer Medical Care Inc.
- Hand Controller Sheath — Bayer Medical Care Inc.
- Hand Controller Sheath — Bayer Medical Care Inc.
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care Inc.
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care Inc.
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care Inc.
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 (2)
- FDA UDI f5a8e3bb-b0d2-4c75-ac5b-b17482f032d2 38 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026