← Back to catalogue

MEDRAD® Mark 7 Arterion Injection System

FDA UDI

Class II (US FDA UDI)

by Bayer Medical Care Inc.

Identity

Trade Name
MEDRAD® Mark 7 Arterion Injection System FDA UDI
Generic Name
Contrast medium injection system hand controller kit FDA UDI
Device Name
"ASSY, CA, HANDSWITCH, EXTENDED (85276549)" FDA UDI
Model / Reference
ART 700 HS12 FDA UDI
Description
"ASSY, CA, HANDSWITCH, EXTENDED (85276549)" FDA UDI

Identifiers

Catalog Number
ART 700 HS12 FDA UDI
Primary DI / UDI-DI
00616258009384 FDA UDI
510(k) Number
K112086 FDA UDI
FDA Product Code
DXT FDA UDI
GMDN Term
Contrast medium injection system hand controller kit 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Contrast medium injection system hand controller kit

MEDRAD® Mark 7 Arterion Injection System by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Contrast medium injection system hand controller kit.

Cleared under the same submission

K112086 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

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 (1)

  • FDA UDI 7144d2c3-b31d-46a5-aa2d-7cf55d2ef7fa 36 fields · synced Jun 9, 2026