FDA.reportPublic FDA data

CARDIATEK®

Primary DI
00628678604193
Brand
CARDIATEK®
Company
Technimount Medicale Inc
Model
552-10-AB-BR
Catalog number
552-10-AB-BR
Device description
Reusable dual-disc mounting bracket designed to secure the medical device during emergency, critical-care and hospital transport. The system provides mechanical retention and positioning of the controller while maintaining access to its controls, connectors, cables and associated accessories.
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOXStand, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628678604193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628678604193006286786041936286786041930628678604193

GMDN Terms#

Term, Definition table
TermDefinition
Portable active medical device mountA device intended to be fixed (e.g., to a healthcare facility wall, ambulance, trolley, floor) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount.

Contacts#

Phone, Email table
PhoneEmail
+1 (581) 998-9820customerservice@technimount.com

Regulatory Flags#

DUNS number
204233550
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628678604124Micro Base Pro120-20-UN-510120-20-UN-5102026-09-21
00628678604131PS5000 Clamp Block FQ3420-10-TCPS-FQ-S3420-10-TCPS-FQ-S2026-09-21
00628678604148Bracket Pro Serie® 350 – MD230-12-LP35-MD230-12-LP35-MD2026-09-21
00628678604155Bracket Pro Serie® 360 - FQ3600-10-BD-FQ3600-10-BD-FQ2026-09-21
00628678604162Bracket Pro Serie® 71330-11-PHX3330-11-PHX32026-09-21
00628678604179O2 Mount PS5000OXY-00-TCPSOXY-00-TCPS2026-09-21
00628678604186Bracket Pro Serie® 26 – FQ141-10-ZV-FQ141-10-ZV-FQ2026-09-21
00628678604087ContinuuMed™ RIVCMD-00-TCPS-RIVCMD-00-TCPS-RIV2026-09-18
00628678604094ContinuuMed™ PVTCMD-00-TCPS-PVTCMD-00-TCPS-PVT2026-09-18
00628678604100Standard Surface Base100-20-UN100-20-UN2026-09-18
00628678604117Universal Base101-20-UN101-20-UN2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050863629Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-09-22
00628678604124Micro Base ProTechnimount Medicale IncFOX2026-09-21
00628678604131PS5000 Clamp Block FQTechnimount Medicale IncFOX2026-09-21
00628678604148Bracket Pro Serie® 350 – MDTechnimount Medicale IncFOX2026-09-21
00628678604155Bracket Pro Serie® 360 - FQTechnimount Medicale IncFOX2026-09-21
00628678604162Bracket Pro Serie® 71Technimount Medicale IncFOX2026-09-21
00628678604179O2 Mount PS5000Technimount Medicale IncFOX2026-09-21
00628678604186Bracket Pro Serie® 26 – FQTechnimount Medicale IncFOX2026-09-21
00810050863612Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-09-21
00628678604087ContinuuMed™ RIVTechnimount Medicale IncFOX2026-09-18
00628678604094ContinuuMed™ PVTTechnimount Medicale IncFOX2026-09-18
00628678604100Standard Surface BaseTechnimount Medicale IncFOX2026-09-18
00628678604117Universal BaseTechnimount Medicale IncFOX2026-09-18
00810050863544Arch InstallationLIFEPORT, LLCFOX2026-08-25
00810050863551IV PoleLIFEPORT, LLCFOX2026-08-25
00810050863568Arch InstallationLIFEPORT, LLCFOX2026-08-25
00810050863575Arch AssemblyLIFEPORT, LLCFOX2026-08-25
00810050863506Medical CabinetLIFEPORT, LLCFOX2026-08-03
00841027105695Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2026-06-26
00810050863483AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-06-08
00840117346307Vital Signs Stand, Compatible with item 10843Dynarex CorporationFOX2026-06-08
00761887005471PryorPRYOR PRODUCTSFOX2026-05-31
04061162002116CIM med GmbHCIM med GmbHFOX2026-05-31
04061162051893CIM med GmbHCIM med GmbHFOX2026-05-31
00885403530145TRUCLIPBecton, Dickinson And CompanyFOX2026-05-30
00840432200056Verathon®Verathon Medical (Canada) ULCFOX2026-05-28
00761887005426PryorPRYOR PRODUCTSFOX2026-05-21
00810050863445Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863452Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863414Pole MountLIFEPORT, LLCFOX2026-04-28