FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450031186
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K08-02688B
Published
2026-02-05
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
10884450031183PackageGS120In Commercial Distribution
20884450031180PackageGS14In Commercial Distribution
00884450031186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445003118310884450031183
2088445003118020884450031180
00884450031186008844500311868844500311860884450031186

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
00884450031131Merit Medical®Initial ReleaseK08-02653A2026-05-28
00884450392850SCOUT MD™Initial ReleaseMDS05A-012026-05-28
00884450392867SCOUT MD™Initial ReleaseMDS05B-012026-05-28
00884450392874SCOUT MD™Initial ReleaseMDS05C-012026-05-28
00884450392881SCOUT MD™Initial ReleaseMDS05M-012026-05-28
00884450392935SCOUT MD™Initial ReleaseMDS75A-012026-05-28
00884450392942SCOUT MD™Initial ReleaseMDS75B-012026-05-28
00884450392959SCOUT MD™Initial ReleaseMDS75C-012026-05-28
00884450392966SCOUT MD™Initial ReleaseMDS75M-012026-05-28
00884450428313Merit Medical®Initial ReleaseK09-09671B2026-05-28
00884450430057Merit Medical®Initial ReleaseK12-01244B2026-05-28
00884450487532Merit Medical®Initial ReleaseK09T-136472026-05-28
00884450487549Merit Medical®Initial ReleaseK12T-11710A2026-05-28
00884450487679Merit Medical®Initial ReleaseK10T-06195A2026-05-28
00884450766958Performa®B1623-F820M2026-05-28
10884450415358Prelude®JPSI-4F-23MT2026-05-28
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00884450027189Merit Medical®Merit Medical Systems, Inc.OJA2026-01-30
00884450029275Merit Medical®Merit Medical Systems, Inc.OJA2026-01-27
00884450027172Merit Medical®Merit Medical Systems, Inc.OJA2026-01-15
00884450027271Merit Medical®Merit Medical Systems, Inc.OJA2026-01-15