FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450498996
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-14391
Published
2026-07-30
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450498993PackageGS110In Commercial Distribution
20884450498990PackageGS14In Commercial Distribution
00884450498996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445049899310884450498993
2088445049899020884450498990
00884450498996008844504989968844504989960884450498996

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
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
00884450376867Merit Medical®Initial ReleaseK09-10502F2026-09-26
00884450431597Merit Medical®Initial ReleaseK09-12862A2026-09-26
00884450432105Merit Medical®Initial ReleaseK09-08926B2026-09-26
00884450707104Merit Medical®DTS1202026-09-26
00884450707111Merit Medical®DTS2202026-09-26
00884450028605Merit Medical®Initial ReleaseK08-01254A2026-09-24
00884450277652Safety Paracentesis Procedure TrayInitial ReleaseSPPT-8F-10S2026-09-22
00884450416723SureCrossDSC18652026-09-22
00884450422755SureCrossDSC14902026-09-22
00884450423110SureCrossDSC14652026-09-22
00884450427170SureCrossDSC141352026-09-22
00884450428016Merit Medical®Initial ReleaseK10-03360H2026-09-22
00884450435526Merit Medical®Initial ReleaseK09-11159A2026-09-22
00884450445419Merit Medical®Initial ReleaseK09-01589X2026-09-22
00884450473313Merit Medical®Initial ReleaseK09-14357A2026-09-22
00884450852279Merit Medical®Initial ReleasePC8112026-09-22
00884450852286Merit Medical®Initial ReleasePC8122026-09-22
10884450489809Prelude SNAP™APLSX-25112026-09-22
10884450489816Prelude SNAP™APLSS-10062026-09-22
10884450489823Prelude SNAP™APLSS-10072026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450376867Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
00884450431597Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
00884450432105Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
B098AMS195240Aligned Medical SolutionsAligned Medical SolutionsOEZ2026-09-26
10197106992753CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956169357CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956444263CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956466159CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956494923CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956529540CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956541566CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956547506CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956553835CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956562035CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956562820CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956570689CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956570863CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956577640CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956578388CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956580145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956582439CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583283CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583320CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583412CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583665CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583726CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584501CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584518CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584839CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956585201CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25