FDA.reportPublic FDA data

Retia Medical

Primary DI
00860001506402
Brand
Retia Medical
Company
RETIA MEDICAL, LLC
Model
FG-001
Device description
The Argos Cardiac Output monitoring device is intended for use on patients above the age of 18. It is intended to be used as a hemodynamic monitor for monitoring cardiac output and its derived parameters on patients in the intensive care unit or the operating room.
Published
2019-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXGComputer, Diagnostic, Pre-Programmed, Single-Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181372000ArgosRetia Medical, LLC2018-12-13DXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001506402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001506402008600015064028600015064020860001506402

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive haemodynamic monitoring systemAn assembly of mains electricity (AC-powered) devices intended to be used for the noninvasive continuous measurement of arterial blood pressure, cardiac output, and other haemodynamic variables by automated radial arterial tonometry. It consists of a bracelet-like detection device worn on the wrist and an attached monitor with user interface. It is typically used in the operating arena or the intensive care unit (ICU).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(914) 594-1986HAgashe@mkmventuresllc.com

Regulatory Flags#

DUNS number
025675871
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044487042Retia MedicalFG-001-RFBFG-001-RFB2026-04-16
00850044487103Retia Medical30-01230-0122026-04-16
00850044487110Retia Medical30-06830-0682026-04-16
00850044487127Retia Medical30-06530-0652026-04-16
00850044487134Retia Medical30-06930-0692026-04-16
00850044487011Retia MedicalFG-012FG-0122024-02-01
00850044487004Retia MedicalFG-011FG-0112023-02-21
00860001506488Retia MedicalFG-0092022-03-22
00860001506495Retia MedicalFG-0102021-12-29
00860001506471Retia MedicalFG-0082021-04-05
00860001506464Retia MedicalFG-0072020-04-10
00860001506419Retia MedicalFG-0022019-05-24
00860001506426Retia MedicalFG-0032019-05-24
00860001506433Retia MedicalFG-0042019-05-24
00860001506440Retia MedicalFG-0052019-05-24
00860001506457Retia MedicalFG-0062019-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864609000348VitalStream ART Connect; VitalStream Hemo; ART DockCARETAKER MEDICAL, LLCDXG2026-06-02
00850044487042Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487103Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487110Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487127Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487134Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDXG2026-04-15
00198953049181NAGE Healthcare Finland OyDXG2026-01-05
00198953066560NAGE Healthcare Finland OyDXG2026-01-05
07290020154101BB-613W Wrist-MonitorBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
07290020154309BB-613 H@H kitBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
00843997001823LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997002882LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017428LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017435LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017190LiDCOMASIMO CORPORATIONDXG2024-07-26
09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2024-07-10
00850044487011Retia MedicalRETIA MEDICAL, LLCDXG2024-02-01
17290013030044StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
27290013030041StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
47290013030045StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
07290013030047StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
77290013030046StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDXG2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDXG2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDXG2023-04-19
00195278524089NAGE Healthcare Finland OyDXG2023-04-19
00850044487004Retia MedicalRETIA MEDICAL, LLCDXG2023-02-21
09120073932990CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2022-06-09