FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450021231
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450021231
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450021238PackageGS125In Commercial Distribution
20884450021235PackageGS14In Commercial Distribution
00884450021231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445002123810884450021238
2088445002123520884450021235
00884450021231008844500212318844500212310884450021231

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium injection system administration setA collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer; it is typically made of plastic materials. This is a disposable device which may serve multiple patients before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450421994Merit Medical®Initial ReleaseK12-12513B2026-08-01
00884450447093Merit Medical®Initial ReleaseK09-02692J2026-08-01
00884450468951DuraMax®CH7871030282012026-07-31
00884450500927Merit Medical®Initial ReleaseK12T-02563D2026-08-01
00884450838136Prelude Roadster™APG6F45R2026-07-31
00884450117156Merit Medical®Initial ReleaseK12T-03663D2026-07-30
00884450486191Merit Medical®Initial ReleaseK12T-12644C2026-07-30
00884450486207Merit Medical®Initial ReleaseK12T-12645C2026-07-30
00884450498996Merit Medical®Initial ReleaseK09-143912026-07-30
00884450499207Merit Medical®Initial ReleaseK10T-01528J2026-07-30
00884450587713StabiliT®DDF-5000A2026-07-30
00884450022146One-Step™DOSC-4F-10LT2026-07-29
00884450022160One-Step™DOSC-4F-10T2026-07-29
00884450022184One-Step™DOSC-4F-7LT2026-07-29
00884450022306One-Step™DOSC-4F-7T2026-07-29
00884450022313One-Step™DOSC-5F-10LT2026-07-29
00884450022535One-Step™DOSC-5F-7LT2026-07-29
00884450022559One-Step™DOSC-5F-10S2026-07-29
00884450022566One-Step™DOSC-5F-7S2026-07-29
00884450022573One-Step™DOSC-4F-10L2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23