FDA UDI In Commercial Distribution 🇺🇸 United States

Mobile Monitor Cart System MMCS

DI: 19120075320105 · Model: 1 · medPhoton GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Mobile Monitor Cart System MMCS
Primary DI
19120075320105
Version / Model
1
Catalog Number
A0093
Company Name
medPhoton GmbH
Labeler DUNS
300376801
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-06-10
Public Version
1
Public Version Date
2025-06-18
Public Version Status
New
Public Device Record Key
88612ff6-50ab-477f-bd6f-ed5813ad5b1f

Device Description

Mobile Monitor Cart System "MMCS": The Mobile Monitor Cart System (including the components mounted on it) is intended for use in healthcare facilities in general and near patients in operating theatres. The Mobile Monitor Cart System can be used to move medical equipment (e.g. the IRm control unit) within the building or to position it in the room. If the system is used in conjunction with the IRm operating unit, the mobile monitor cart system expands the display and control options of the mobile X-ray imaging system "ImagingRing m" or "Loop-X®" (abbreviated Rm) of medPhoton GmbH. The mobile monitor cart system is listed and released as an accessory and included in the technical documentation and 510(k) premarket submissions for the ImagingRing m. Therefore it is also registered under the same listing number and product code.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OWB Interventional Fluoroscopic X-Ray System

GMDN Terms

Code Name
36612 Image display unit, colour

Identifiers

Type ID
Primary 19120075320105

Premarket Submissions

Submission Number Supplement Number
K203281 000
K234067 000