FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450485651
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K04-00404B
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJAIntravenous extension tubing set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJAIntravenous Extension Tubing SetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450485658PackageGS125In Commercial Distribution
20884450485655PackageGS14In Commercial Distribution
00884450485651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445048565810884450485658
2088445048565520884450485655
00884450485651008844504856518844504856510884450485651

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic procedure tubingA flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00884450220306Merit Medical®Initial ReleaseK12-126952026-06-03
00884450426630Merit Medical®Initial ReleaseK09-13283C2026-06-03
00884450437438Merit Medical®Initial ReleaseK09-14187A2026-06-03
00884450486887Merit Medical®Initial ReleaseK09-07789R2026-06-03
00884450487006Merit Medical®Initial ReleaseK12-127222026-06-03
10884450706708Prelude®FPSI-4F-23-035MT2026-06-03
00884450424087Merit Medical®Initial ReleaseK09-13251A2026-06-02
00884450431009Merit Medical®Initial ReleaseK08-03026A2026-06-02
00884450435403Merit Medical®Initial ReleaseK09-11196A2026-06-02
00884450457511C2 CryoBalloon™AFG-10242026-06-02
00884450457528C2 CryoBalloon™AFG-10282026-06-02
00884450457566C2 CryoBalloon™AFG-10552026-06-02
00884450457573C2 CryoBalloon™AFG-10562026-06-02
00884450467183Merit Medical®Initial ReleaseK10T-06193A2026-06-02
00884450474549Merit Medical®Initial ReleaseK09-134782026-06-02
00884450474556Merit Medical®Initial ReleaseK09-134792026-06-02
00884450474563Merit Medical®Initial ReleaseK09-136162026-06-02
00884450589977SplashWire™Initial ReleaseMSWSTFA35150LT2026-06-02
00884450794760DuraMax®AH7871030290412026-06-02
00884450376478Merit Medical®Initial ReleaseK09-01002L2026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450431009Merit Medical®Merit Medical Systems, Inc.OJA2026-06-02
00884450031131Merit Medical®Merit Medical Systems, Inc.OJA2026-05-28
00884450029961Merit Medical®Merit Medical Systems, Inc.OJA2026-04-29
08500835120079Start of Care Kit-SubqOptum Distribution Center, LLCOJA2026-04-28
00884450028247Merit Medical®Merit Medical Systems, Inc.OJA2026-04-28
08500835120048Peripheral IV Start KitOptum Distribution Center, LLCOJA2026-04-27
08500835120062PICC Dressing Change KitOptum Distribution Center, LLCOJA2026-04-27
08500835120055PICC Start of Care KitOptum Distribution Center, LLCOJA2026-04-24
08500835120031Infusion Site Change KitOptum Distribution Center, LLCOJA2026-04-22
00884450028254Merit Medical®Merit Medical Systems, Inc.OJA2026-04-21
00860014354809Arpovo HealthARPOVO, LLCOJA2026-04-20
00860014354816Arpovo HealthARPOVO, LLCOJA2026-04-20
00884450029022Merit Medical®Merit Medical Systems, Inc.OJA2026-04-16
00884450025291Merit Medical®Merit Medical Systems, Inc.OJA2026-04-10
00884450027257Merit Medical®Merit Medical Systems, Inc.OJA2026-04-02
00884450028094Merit Medical®Merit Medical Systems, Inc.OJA2026-04-02
00884450031223Merit Medical®Merit Medical Systems, Inc.OJA2026-03-26
00884450029367Merit Medical®Merit Medical Systems, Inc.OJA2026-03-24
00884450027332Merit Medical®Merit Medical Systems, Inc.OJA2026-03-20
00884450031230Merit Medical®Merit Medical Systems, Inc.OJA2026-03-19
00884450029206Merit Medical®Merit Medical Systems, Inc.OJA2026-03-13
00884450029664Merit Medical®Merit Medical Systems, Inc.OJA2026-03-12
00884450029268Merit Medical®Merit Medical Systems, Inc.OJA2026-03-03
00884450029800Merit Medical®Merit Medical Systems, Inc.OJA2026-02-28
00884450028162Merit Medical®Merit Medical Systems, Inc.OJA2026-02-18
00884450027387Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
00884450029015Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
00884450031186Merit Medical®Merit Medical Systems, Inc.OJA2026-02-05
00884450027189Merit Medical®Merit Medical Systems, Inc.OJA2026-01-30
00884450029275Merit Medical®Merit Medical Systems, Inc.OJA2026-01-27