Identity
- Trade Name
- ASSY,CBL,RPC,MN,SHLD,START,SW,UDI,BATCH FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- ASSY,CBL,RPC,MN,SHLD,START,SW,UDI,BATCH (85594370) FDA UDI
- Model / Reference
- RPA 550-1 FDA UDI
- Description
- ASSY,CBL,RPC,MN,SHLD,START,SW,UDI,BATCH (85594370) FDA UDI
Identifiers
- Catalog Number
- RPA 550-1 FDA UDI
- Primary DI / UDI-DI
- 00616258010502 FDA UDI
- 510(k) Number
- K924116 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
No
FDA UDI
Category: CT contrast medium injection system, line-powered, mobile
Assy, Cbl, Rpc, Mn, Shld, Start, Sw, 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
K924116 also covers:
- 200mL Sterile Disposable Qwik-Fit Syringe — Bayer Medical Care Inc.
- 200mL Sterile Disposable Qwik-Fit Syringe — Bayer Medical Care Inc.
- 200mL Sterile Disposable Qwik-Fit Syringe — Bayer Medical Care Inc.
- 200mL Sterile Disposable Qwik-Fit Syringe & QFT — Bayer Medical Care Inc.
- 200mL Sterile Disposable Qwik-Fit Syringe & QFT — Bayer Medical Care Inc.
- 200mL Sterile Disposable Qwik-Fit Syringe & QFT — Bayer Medical Care Inc.
- 200mL Sterile Disposable Qwik-Fit Syringe & QFT — Bayer Medical Care Inc.
- CABLE, START SWITCH, 25FT, 4PIN, UDI, BATCH — Bayer Medical Care Inc.
- CT TRI-PAK Sterile Disposable Syringe — Bayer Medical Care Inc.
- CT TRI-PAK Sterile Disposable Syringe — Bayer Medical Care Inc.
- CT TRI-PAK Sterile Disposable Syringe — Bayer Medical Care Inc.
- CT TRI-PAK Sterile Disposable Syringe — 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 09b2217c-eb10-434b-b682-e3f00e4a063a 36 fields · synced Jun 9, 2026