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MEDRAD® Mark 7 Arterion Footswitch
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref ART 700 FS
Identity
- Trade Name
- MEDRAD® Mark 7 Arterion Injection System EUDAMEDFDA UDIMEDRAD® Mark 7 Arterion Footswitch FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- MEDRAD® Mark 7 Arterion Injection System EUDAMEDASSY,FOOTSWITCH,ARTERION,LR,UDI (87978494) FDA UDIASSY, FOOTSWITCH (85276506) FDA UDIASSY,FOOTSWITCH,ARTERION,LR,UDI (89234522) FDA UDI
- Model / Reference
- ART 700 FS EUDAMEDFDA UDI
- Description
- ASSY,FOOTSWITCH,ARTERION,LR,UDI (87978494) FDA UDIASSY, FOOTSWITCH (85276506) FDA UDIASSY,FOOTSWITCH,ARTERION,LR,UDI (89234522) FDA UDI
Identifiers
- Catalog Number
- ART 700 FS FDA UDI
- Primary DI / UDI-DI
- 00616258025308 EUDAMEDFDA UDI00616258027241 EUDAMEDFDA UDI00616258009346 FDA UDI
- Basic UDI-DI
- 0616258TFCN-0081IIbYU EUDAMED
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A030199 CONTROLLERS - OTHER EUDAMED
- GMDN Term
- Foot-switch, electrical 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 Footswitch by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K112086 also covers:
- MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Handswitch 12’ Optional — Bayer Medical Care Inc.
- MEDRAD® Mark 7 Arterion Handswitch 6’ Standard — Bayer Medical Care Inc.
- 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.
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 (6)
- FDA UDI 3b06ab2b-22f5-42f4-9b32-ff89baceb914 37 fields · synced Oct 7, 2026
- FDA UDI a0d0a4ee-242c-47be-97ca-315b7c9e2112 36 fields · synced May 29, 2026
- FDA UDI ad5c4d2a-d79b-46ee-81e4-e7a9d5766ffb 38 fields · synced May 30, 2026
- EUDAMED ee783987-cebf-4e2e-b32d-f1118bad16e3 61 fields · synced Jul 15, 2026
- EUDAMED 375a0b4b-4f23-47f2-9a95-b451de7bc086 61 fields · synced Sep 17, 2026
- EUDAMED fb8dd227-e580-42b9-8a19-0d51a02bd80d 61 fields · synced Oct 6, 2026