FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450326463
Brand
Merit Medical®
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
10884450326463
Published
2018-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DSKCOMPUTER, BLOOD-PRESSURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSKComputer, Blood-PressureCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450326460PackageGS110In Commercial Distribution
10884450326463PrimaryGS10
00884450326466Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445032646020884450326460
1088445032646310884450326463
00884450326466008844503264668844503264660884450326466

GMDN Terms#

Term, Definition table
TermDefinition
In-line arterial blood sampling setA collection of sterile devices designed to obtain an in-line arterial blood specimen while maintaining a closed system. It is a haemodynamic pressure monitoring and blood gas sampling device, typically designed for use with disposable/reusable pressure transducers, intended to connect to a central line/arterial catheter from which the blood specimen is obtained. Heparinized blood may be reinfused into the patient via the device to reduce fluid loss. This is a single-patient device that may be used short term (single-use) before being discarded.

Regulatory Flags#

DUNS number
595138793
Device count
50
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
10884450322564Meritrans DTXPlus®108844503225642018-01-26
10884450323905Critiflo™108844503239052018-01-30
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
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00850022994463Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994470Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994487Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994524Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994531Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994548Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994555Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00883873760420ASSY,CABLE,ADAPTER,TEMPERATURE,M-PAK,LP35,10FTPHYSIO-CONTROL, INC.DSK2025-09-26
00883873760437ASSY, CABLE, ADAPTER, TEMP, LP35, 6FT,IRONGANPHYSIO-CONTROL, INC.DSK2025-09-26
00883873760444ASSY, CABLE, ADAPTER, IP, ICU, LP35PHYSIO-CONTROL, INC.DSK2025-09-26
00883873760451ASSY, CABLE, ADAPTER, IP, EDWARDS, LP35PHYSIO-CONTROL, INC.DSK2025-09-26
00850022994401Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-09-08
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00845225012762IVUS-PIMPhilips Image Guided Therapy CorporationDSK2025-03-24
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSK2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSK2024-12-19
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