FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450445419
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-01589X
Published
2026-09-22
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
10884450445416PackageGS110In Commercial Distribution
20884450445413PackageGS14In Commercial Distribution
00884450445419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445044541610884450445416
2088445044541320884450445413
00884450445419008844504454198844504454190884450445419

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium injection system administration setA collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer; it is typically made of plastic materials. This is a disposable device which may serve multiple patients before being discarded.

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
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
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
10884450489830Prelude SNAP™APLSS-10082026-09-22
10884450489847Prelude SNAP™APLSS-1008.52026-09-22
10884450489854Prelude SNAP™APLSS-10092026-09-22
10884450489861Prelude SNAP™APLSS-1009.52026-09-22
10884450489878Prelude SNAP™APLSS-10102026-09-22
10884450489885Prelude SNAP™APLSS-1010.52026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450435526Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-22
00884450473313Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-22
10198956508903CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956520554CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956520783CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956524255CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956547384CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956566750CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956571464CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956575080CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956575950CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956578104CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956579347CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956579606CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956579682CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956580572CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956580657CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956580817CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956581289CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956581531CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956582101CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956582460CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956582750CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956583214CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956583351CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956583429CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956584631CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956585171CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956585812CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956585911CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22