← Back to catalogue
MEDRAD® Mark 7 Arterion Handswitch 12’ Optional
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref ART 700 HS12
Identity
- Trade Name
- MEDRAD® Mark 7 Arterion Injection System EUDAMEDMEDRAD® Mark 7 Arterion Handswitch 12’ Optional FDA UDI
- Generic Name
- Contrast medium injection system hand controller kit FDA UDI
- Device Name
- MEDRAD® Mark 7 Arterion Injection System EUDAMEDASSY,CBL,HANDSWITCH,EXTENDED,LR,UDI (89234530) FDA UDI
- Model / Reference
- ART 700 HS12 EUDAMEDFDA UDI
- Description
- ASSY,CBL,HANDSWITCH,EXTENDED,LR,UDI (89234530) FDA UDI
Identifiers
- Catalog Number
- ART 700 HS12 FDA UDI
- Primary DI / UDI-DI
- 00616258027227 EUDAMEDFDA UDI
- Basic UDI-DI
- 0616258TFCN-0081IIbYU EUDAMED
- 510(k) Number
- K113133 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A030199 CONTROLLERS - OTHER EUDAMED
- GMDN Term
- Contrast medium injection system hand controller kit FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MEDRAD® Mark 7 Arterion Handswitch 12’ Optional by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K113133 also covers:
- MEDRAD® Mark 7 Arterion Heat Maintainer, Syringe — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Injection System — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Injection System — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Injection System — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Injection System — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Injection System — 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 (2)
- FDA UDI 34b03884-2a28-4ec9-9e8a-9ebdeb7c5664 38 fields · synced Oct 7, 2026
- EUDAMED eb2557bd-b547-4b67-b748-ddcb321573aa 61 fields · synced Jul 31, 2026