iMap Computer Cart

Primary DI
00850012226406
Brand
iMap Computer Cart
Company
Cardionxt Inc
Model
825500
Published
2026-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QLJPatient Monitor With Independent Remote Display And Operation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLJPatient Monitor With Independent Remote Display And OperationUnknownN

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201094000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201094000iMap 3D Mapping & Navigation System (iMap System)Cardionxt, Inc.2021-08-16DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012226406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012226406008500122264068500122264060850012226406

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical device/system transport trolleyA 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.

Regulatory Flags#

DUNS number
117364041
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012226338iMap Software8205012026-04-09
00850012226291iMap 3D Mapping and Navigation System8200002025-12-10
00850012226000Axis Patient Patches8210102025-12-10
00850012226154Multilink CS Catheter8210032025-12-10