Identity
- Trade Name
- CABLE,FOOT SWITCH ASSY,UDI,BATCH FDA UDI
- Generic Name
- Angiography contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- CABLE,FOOT SWITCH ASSY,UDI,BATCH (85594354) FDA UDI
- Model / Reference
- KMA 562-1 FDA UDI
- Description
- CABLE,FOOT SWITCH ASSY,UDI,BATCH (85594354) FDA UDI
Identifiers
- Catalog Number
- KMA 562-1 FDA UDI
- Primary DI / UDI-DI
- 00616258010496 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
Cable, Foot Switch Assy, Udi, Batch by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Angiography contrast medium injection system, line-powered, mobile.
- CVi® Accessory — ACIST Medical Systems, Inc. · Class II
- CVi® Cable — ACIST Medical Systems, Inc. · Class II
- CVi® Cable — ACIST Medical Systems, Inc. · Class II
- CVi® Accessory — ACIST Medical Systems, Inc. · Class II
- ACIST CVi® Contrast Delivery System Power Supply — ACIST Medical Systems, Inc. · Class II
- CVi® Cable — ACIST Medical Systems, Inc. · Class II
- CVi® Cable — ACIST Medical Systems, Inc. · Class II
- CVi® Bed Mount — ACIST Medical Systems, Inc. · Class II
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.
- ASSY, CBL, STRT SW, REMOTE, PROVIS, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bayer Medical Care Inc.
Sources (1)
- FDA UDI 0de731bb-d541-4a2c-8310-6946d837ef83 36 fields · synced Jun 9, 2026