FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450361051
Brand
Merit Medical®
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
00884450361054
Catalog number
684072/A
Published
2020-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
true

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
K861092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861092000MODEL SP1465 CARDIAC OUTPUT COMPUTERGould, Inc.1986-08-18DXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450361051PackageGS11In Commercial Distribution
00884450361054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445036105110884450361051
00884450361054008844503610548844503610540884450361054

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
595138793
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
10884450321031Exacta™10884450321031680124/A2021-02-16
10884450321048Exacta™10884450321048680126/A2019-05-28
10884450321055Exacta™10884450321055680128/A2019-06-03
10884450321062Exacta™10884450321062680140/A2019-07-05
10884450389994Exacta™10884450389994680132/A2019-09-04
00886333610006SECALON T 18G/1.25 X 90MM MULT=25/2506810006810002016-09-24
00886333610020SECALON T 16G/1.70 X 130MM MULT=25/2506810026810022016-09-30
00886333610044SECALON T 16G/1.70 X 160MM MULT=25/2506810046810042016-09-23
00886333616121CAREFLOW(TM) 1 LUMEN 2.5FR X 60MM6816126816122016-09-24
00886333616145CAREFLOW(TM) 1 LUMEN 2.5FR X 100MM6816146816142016-09-24
00886333616152CAREFLOW(TM) 1 LUMEN 2.5FR X 60MM6816156816152016-09-24
00886333616169CAREFLOW(TM) 2 LUMEN 4FR X 60MM6816166816162016-09-24
00886333616176CAREFLOW(TM) 2 LUMEN 4FR X 60MM6816176816172016-09-24
00886333616183CAREFLOW(TM) 3 LUMEN 5FR X 100MM6816186816182016-09-24
00886333616190CAREFLOW(TM) 2 LUMEN 5FR X 60MM6816196816192016-09-24
00886333616206CAREFLOW(TM) 3 LUMEN 5FR X 60MM6816206816202016-09-24
00886333616220CAREFLOW(TM) 1 LUMEN 2.5FR X 100MM6816226816222016-09-24
00886333616237CAREFLOW(TM) 1 LUMEN 2.5FR X 100MM6816236816232016-09-24
00886333616244CAREFLOW(TM) 1 LUMEN 4FR X 60MM6816246816242016-09-24
00886333616251CAREFLOW(TM) 1 LUMEN 4FR X 60MM6816256816252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403533122ECG Slave Cable for Spaclab PCI and PC2 with PigtailBecton, Dickinson And CompanyDXG2026-09-18
00885403533146TruWave Reusable CableBecton, Dickinson And CompanyDXG2026-09-18
00885403533153ECG Slave Cable for Spaclab PCI and PC2 with PigtailBecton, Dickinson And CompanyDXG2026-09-18
00885403533160TruWave Reusable CableBecton, Dickinson And CompanyDXG2026-09-18
00885403533610TruWave Reusable CableBecton, Dickinson And CompanyDXG2026-09-18
00885403533634Pressure Slave CableBecton, Dickinson And CompanyDXG2026-09-18
00885403533641Cable COO Catheter InterfaceBecton, Dickinson And CompanyDXG2026-09-18
00885403529781ClearSightBecton, Dickinson And CompanyDXG2026-07-29
00885403529798ClearSightBecton, Dickinson And CompanyDXG2026-07-29
00885403529811ClearSightBecton, Dickinson And CompanyDXG2026-07-29
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