FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450028094
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K08-00633C
Published
2026-04-02
Public version status
New
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
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
10884450028091PackageGS115In Commercial Distribution
20884450028098PackageGS14In Commercial Distribution
00884450028094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445002809110884450028091
2088445002809820884450028098
00884450028094008844500280948844500280940884450028094

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450148228Merit Medical®Initial ReleaseK09-09226C2026-08-19
00884450428474Merit Medical®Initial ReleaseK10-04389A2026-08-19
00884450432365Merit Medical®Initial ReleaseK10-05106A2026-08-18
00884450476079CorVocet™BCORA1410S2026-08-18
00884450476093CorVocet™BCORA14152026-08-18
00884450838211Prelude Roadster™APG7F45SX2026-08-18
00884450457535C2 CryoBalloon™AFG-10402026-08-17
00884450458204DuraMax®BH7871030280312026-08-17
00884450531969Prelude Roadster™00884450531969PG6F45S2022-07-20
00884450122471Merit Medical®Initial ReleaseK08-01887B2026-08-14
00884450428245Merit Medical®Initial ReleaseK10-05700A2026-08-15
00884450467220Merit Medical®Initial ReleaseK09-05248N2026-08-14
00884450488775Merit Medical®Initial ReleaseK10T-04423Q2026-08-14
00884450488843Merit Medical®Initial ReleaseK12T-127422026-08-15
00884450110164Merit Disposal Depot™Initial ReleaseK10-00230D2026-08-07
00884450487402Merit Medical®Initial ReleaseK01-083682026-08-07
00884450500859Merit Medical®Initial ReleaseK09-10938D2026-08-08
00884450421994Merit Medical®Initial ReleaseK12-12513B2026-08-01
00884450447093Merit Medical®Initial ReleaseK09-02692J2026-08-01
00884450468951DuraMax®CH7871030282012026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450122471Merit Medical®Merit Medical Systems, Inc.OJA2026-08-14
00884450029695Merit Medical®Merit Medical Systems, Inc.OJA2026-07-24
00884450433812Merit Medical®Merit Medical Systems, Inc.OJA2026-07-23
00884450030592Merit Medical®Merit Medical Systems, Inc.OJA2026-06-06
00884450485651Merit Medical®Merit Medical Systems, Inc.OJA2026-06-03
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
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