Identity
- Trade Name
- ASSY,CBL,STRT SW,REMOTE,PROVIS,UDI,BATCH FDA UDI
- Generic Name
- Angiography contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- ASSY,CBL,STRT SW,REMOTE,PROVIS,UDI,BATCH (85594141) FDA UDI
- Model / Reference
- RPA 550IR FDA UDI
- Description
- ASSY,CBL,STRT SW,REMOTE,PROVIS,UDI,BATCH (85594141) FDA UDI
Identifiers
- Catalog Number
- RPA 550IR FDA UDI
- Primary DI / UDI-DI
- 00616258010434 FDA UDI
- 510(k) Number
- K903390 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Angiography contrast medium injection system, line-powered, mobile
Assy, Cbl, Strt Sw, Remote, Provis, Udi, Batch by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K903390 also covers:
- ASSY, CBL, STRT SW, AUX, 25FT, PROV, UDI, BATCH — Bayer Medical Care Inc.
- ASSY, CBL, STRT SW, AUX, 60FT, PROV, UDI, BATCH — Bayer Medical Care Inc.
- ASSY, CBL, STRT SW, AUX, 85FT, PRO, UDI, BATCH — Bayer Medical Care Inc.
- CABLE, FOOT SWITCH ASSY, UDI, BATCH — Bayer Medical Care Inc.
- MEDRAD Mark V Provis Foot Switch with Cable — Bayer Medical Care Inc.
- MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe — Bayer Medical Care Inc.
- MEDRAD® Mark V ProVis Sterile Disposable Syringe 150mL & QFT — 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 05c3eb98-1a42-4863-a39b-5ce8c04475c7 36 fields · synced Jun 9, 2026