FDA.reportPublic FDA data

Meritrans DTXPlus®

Primary DI
10884450322564
Brand
Meritrans DTXPlus®
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
10884450322564
Published
2018-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450322561PackageGS110In Commercial Distribution
10884450322564PrimaryGS10
00884450322567Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445032256120884450322561
1088445032256410884450322564
00884450322567008844503225678844503225670884450322567

GMDN Terms#

Term, Definition table
TermDefinition
Invasive-pressure external transducer, single-useA sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.

Regulatory Flags#

DUNS number
595138793
Device count
10
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884450321505Careflow™10884450321505681631/A2022-09-20
10884450321567Careflow™108844503215672018-07-19
10884450321598Careflow™108844503215982018-07-19
10884450363956RadialFlo™108844503639562019-02-28
10884450322557Meritrans DTXPlus®108844503225572018-01-26
10884450323905Critiflo™108844503239052018-01-30
10884450326463Merit Medical®108844503264632018-01-26
10884450360467Merit Medical®108844503604672018-08-06
10884450360474Merit Medical®108844503604742018-12-13
10884450360481Merit Medical®108844503604812018-09-10
10884450360498Merit Medical®108844503604982018-03-19
10884450360504Merit Medical®108844503605042018-05-22
10884450360511Merit Medical®108844503605112018-09-17
10884450360535Meritrans DTXPlus®108844503605352018-12-03
10884450360689Meritrans DTXPlus®108844503606892018-02-14
10884450360702Meritrans DTXPlus®108844503607022018-11-06
10884450360764Meritrans DTXPlus®108844503607642018-04-11
10884450360825Meritrans DTXPlus®108844503608252018-05-01
10884450371753Meritrans DTXPlus®108844503717532019-10-11
10884450371876Merit Medical®108844503718762019-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
00856324008778PARAMEDSILEX GLOBAL LLCDXN2026-08-22
06971522821753LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06971522821760LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06953825911805FOCUSED ADULT ADHD CLINICShenzhen Urion Technology Co., LtdDXN2026-08-19
09120073932778CNAP® ArmslingCNSystems Medizintechnik GmbHDXN2026-08-18
09120073932785CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932792CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932808CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932815CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932846CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932877CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
06953825911799SAKERShenzhen Urion Technology Co., LtdDXN2026-08-17
06920485308542BSXShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-14
00057475244125BIOS DiagnosticsThermor LtdDXN2026-08-07
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911706SAKERShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01