FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450431443
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K08-03296A
Published
2026-11-04
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
10884450431440PackageGS115In Commercial Distribution
20884450431447PackageGS14In Commercial Distribution
00884450431443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445043144010884450431440
2088445043144720884450431447
00884450431443008844504314438844504314430884450431443

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
00884450163917Merit Medical®Initial ReleaseK09-12030B2026-11-04
00884450456385ReSolve®GRBDC-14-0382026-11-04
00884450503829Merit Medical®Initial ReleaseK09-13310D2026-11-04
00884450794739DuraMax®AH7871030290152026-11-03
00884450838228Prelude Roadster™APG8F45S2026-11-03
00884450839355Prelude Roadster™APG7F90SX2026-11-04
10884450708467Prelude®FPSI-7F-11-038-18G2026-11-03
00884450148174Merit Medical®Initial ReleaseK09-09012A2026-10-31
00884450428061Merit Medical®Initial ReleaseK10-01518B2026-10-31
00884450436936Merit Medical®Initial ReleaseK12-07972A2026-10-30
00884450499191Merit MAK™GMAK401N-E2026-10-30
00884450499221Merit MAK™GMAK401N2026-10-30
00884450499245Merit MAK™FMAK501N2026-10-30
00884450499870Merit S-MAK™FS-MAK501N2026-10-30
00884450500033Merit Medical®Initial ReleaseK09-05053T2026-10-30
00884450839362Prelude Roadster™APG8F45SX2026-10-30
00884450254677Merit Medical®Initial ReleaseK12-082752026-10-29
00884450838129Prelude Roadster™APG6F45MP2026-10-29
10884450708443Prelude®FPSI-7F-11-035-18G2026-10-29
00884450429150Merit Medical®Initial ReleaseK12-11133A2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450029756Merit Medical®Merit Medical Systems, Inc.OJA2026-09-29
00884450028605Merit Medical®Merit Medical Systems, Inc.OJA2026-09-24
00884450121368Merit Medical®Merit Medical Systems, Inc.OJA2026-09-19
00884450030301Merit Medical®Merit Medical Systems, Inc.OJA2026-09-18
00884450029701Merit Medical®Merit Medical Systems, Inc.OJA2026-08-26
00884450122402Merit Medical®Merit Medical Systems, Inc.OJA2026-08-22
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
00884450028094Merit Medical®Merit Medical Systems, Inc.OJA2026-04-02
00884450029367Merit Medical®Merit Medical Systems, Inc.OJA2026-03-24
00884450027332Merit Medical®Merit Medical Systems, Inc.OJA2026-03-20
00884450029206Merit Medical®Merit Medical Systems, Inc.OJA2026-03-13