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MEDRAD® Mark 7 Arterion Handswitch 6’ Standard

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref ART 700 HS6Ref ART 700Ref VF HCRef ART 700 FSRef ART 700 HS12

by Bayer Medical Care Inc.

Identity

Trade Name
MEDRAD® Mark 7 Arterion Injection System EUDAMEDFDA UDI
MEDRAD® Mark 7 Arterion Handswitch 6’ Standard FDA UDI
MEDRAD® Mark 7 Arterion Footswitch FDA UDI
MEDRAD® Vflow Disposable Hand Controller FDA UDI
MEDRAD® Mark 7 Arterion Handswitch 12’ Optional FDA UDI
Generic Name
Contrast medium injection system hand controller kit FDA UDI
Foot-switch, electrical FDA UDI
Angiography contrast medium injection system, line-powered, mobile FDA UDI
Device Name
MEDRAD® Mark 7 Arterion Injection System EUDAMED
ASSY,CBL,HANDSWITCH,LR,UDI (87978486) FDA UDI
ASSY,FOOTSWITCH,ARTERION,LR,UDI (87978494) FDA UDI
ASSY, FOOTSWITCH (85276506) FDA UDI
MARK 7 ARTERION,PKGD,BASE SYSTEM,4th MC (86410095) FDA UDI
"MARK 7 ARTERION, PACKAGED, BASE SYSTEM (60726793)" FDA UDI
"Twist & Go Hand Controller Single (ANGIO - ART, VFLOW HAND CONTROLLER, MC) (84217107)" FDA UDI
ASSY,CBL,HANDSWITCH,EXTENDED,LR,UDI (89234530) FDA UDI
ASSY,FOOTSWITCH,ARTERION,LR,UDI (89234522) FDA UDI
Model / Reference
ART 700 HS6 EUDAMEDFDA UDI
ART 700 FS EUDAMEDFDA UDI
VF HC EUDAMEDFDA UDI
ART 700 HS12 EUDAMEDFDA UDI
ART 700 EUDAMED
Arterion FDA UDI
Description
ASSY,CBL,HANDSWITCH,LR,UDI (87978486) FDA UDI
ASSY,FOOTSWITCH,ARTERION,LR,UDI (87978494) FDA UDI
ASSY, FOOTSWITCH (85276506) FDA UDI
MARK 7 ARTERION,PKGD,BASE SYSTEM,4th MC (86410095) FDA UDI
"MARK 7 ARTERION, PACKAGED, BASE SYSTEM (60726793)" FDA UDI
"Twist & Go Hand Controller Single (ANGIO - ART, VFLOW HAND CONTROLLER, MC) (84217107)" FDA UDI
ASSY,CBL,HANDSWITCH,EXTENDED,LR,UDI (89234530) FDA UDI
ASSY,FOOTSWITCH,ARTERION,LR,UDI (89234522) FDA UDI

Identifiers

Catalog Number
ART 700 HS6 FDA UDI
ART 700 FS FDA UDI
ART 700 PEDL, ART 700 TABL, ART 700 OCS, ART 700 BASC, ART 700 VFL FDA UDI
VF HC FDA UDI
ART 700 HS12 FDA UDI
Primary DI / UDI-DI
00616258025315 EUDAMEDFDA UDI
00616258025308 EUDAMEDFDA UDI
00616258021362 EUDAMEDFDA UDI
00616258009360 EUDAMEDFDA UDI
00616258006994 EUDAMEDFDA UDI
00616258027227 EUDAMEDFDA UDI
00616258027241 EUDAMEDFDA UDI
00616258009346 FDA UDI
Basic UDI-DI
0616258TFCN-0081IIbYU EUDAMED
510(k) Number
K112086 FDA UDI
K132928 FDA UDI
K113133 FDA UDI
FDA Product Code
DXT FDA UDI
EMDN Code
A030199 CONTROLLERS - OTHER EUDAMED
Z11039013 ANGIOGRAPHIC INJECTORS EUDAMED
GMDN Term
Contrast medium injection system hand controller kit FDA UDI
Foot-switch, electrical FDA UDI
Angiography contrast medium injection system, line-powered, mobile FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class 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 UDIEUDAMEDFDA UDI

Single Use

No

FDA UDIFDA 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 UDIFDA UDI

Serial Number

Yes

FDA UDIFDA UDI

Expiration Date

No

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Contrast medium injection system hand controller kit

MEDRAD® Mark 7 Arterion Handswitch 6’ Standard by Bayer Medical Care Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Contrast medium injection system hand controller kit.

Cleared under the same submission

K112086 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bayer Medical Care Inc.

Sources (15)

  • FDA UDI 0c7b9739-6040-4deb-91f4-dcf8e6f52986 37 fields · synced Sep 30, 2026
  • FDA UDI 3b06ab2b-22f5-42f4-9b32-ff89baceb914 37 fields · synced May 24, 2026
  • FDA UDI a0d0a4ee-242c-47be-97ca-315b7c9e2112 36 fields · synced May 29, 2026
  • FDA UDI 7f0ea2d1-fc6b-447a-b983-47beef1ec619 36 fields · synced May 30, 2026
  • FDA UDI 6dd65e7d-71c1-4174-a501-13d10d4762de 36 fields · synced May 30, 2026
  • FDA UDI 021ba8b5-e22d-4714-8af1-03c762cfe304 36 fields · synced May 30, 2026
  • FDA UDI 34b03884-2a28-4ec9-9e8a-9ebdeb7c5664 38 fields · synced May 30, 2026
  • FDA UDI ad5c4d2a-d79b-46ee-81e4-e7a9d5766ffb 38 fields · synced May 30, 2026
  • EUDAMED 12196bed-31ec-4225-ba82-4e62931694ba 61 fields · synced Jul 8, 2026
  • EUDAMED d3b55e0e-212b-427d-ad69-44816f65b7df 61 fields · synced Jul 10, 2026
  • EUDAMED 114eccaa-ab98-4169-847f-4e681f50e639 61 fields · synced Jul 11, 2026
  • EUDAMED ee783987-cebf-4e2e-b32d-f1118bad16e3 61 fields · synced Jul 15, 2026
  • EUDAMED d07cc801-e2fd-43dc-a129-7e67a110fba8 61 fields · synced Jul 25, 2026
  • EUDAMED eb2557bd-b547-4b67-b748-ddcb321573aa 61 fields · synced Jul 31, 2026
  • EUDAMED 375a0b4b-4f23-47f2-9a95-b451de7bc086 61 fields · synced Sep 17, 2026