iMap Computer Cart

Basic Information

• Brand Name: iMap Computer Cart
• Primary DI: 00850012226406
• Version / Model: 825500
• Company Name: Cardionxt Inc
• Labeler DUNS: 117364041
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-09
• Public Version: 1
• Public Version Date: 2026-04-17
• Public Version Status: New
• Public Device Record Key: 892569c5-eb0d-40ab-a4a5-d84de8b23dd7

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QLJ	Patient Monitor With Independent Remote Display And Operation	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
40596	Electromechanical device/system transport trolley	A mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850012226406	GS1

Premarket Submissions

Submission Number	Supplement Number
K201094	000