FDA.reportPublic FDA data

Retia Medical

Primary DI
00850044487110
Brand
Retia Medical
Company
RETIA MEDICAL, LLC
Model
30-068
Catalog number
30-068
Device description
381002-D01 8.20' (2.50m) Power Cord Black CEI 23-50 To IEC 320-C13 H05VV-F - Italy
Published
2026-04-16
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
00850044487110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044487110008500444871108500444871100850044487110

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).

Contacts#

Phone, Email table
PhoneEmail
5854569543tluddy@retiamedical.com

Regulatory Flags#

DUNS number
025675871
Device count
1
Lot or batch
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
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
00860001506402Retia MedicalFG-0012019-04-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044487042Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487103Retia 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
00840682146111CARESCAPE B650GE Healthcare Finland OyDXG2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyDXG2022-05-13