FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450144046
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K09-04088M
Published
2026-07-28
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
10884450144043PackageGS16In Commercial Distribution
20884450144040PackageGS12In Commercial Distribution
00884450144046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445014404310884450144043
2088445014404020884450144040
00884450144046008844501440468844501440460884450144046

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
00884450117156Merit Medical®Initial ReleaseK12T-03663D2026-07-30
00884450486191Merit Medical®Initial ReleaseK12T-12644C2026-07-30
00884450486207Merit Medical®Initial ReleaseK12T-12645C2026-07-30
00884450498996Merit Medical®Initial ReleaseK09-143912026-07-30
00884450499207Merit Medical®Initial ReleaseK10T-01528J2026-07-30
00884450587713StabiliT®DDF-5000A2026-07-30
00884450022146One-Step™DOSC-4F-10LT2026-07-29
00884450022160One-Step™DOSC-4F-10T2026-07-29
00884450022184One-Step™DOSC-4F-7LT2026-07-29
00884450022306One-Step™DOSC-4F-7T2026-07-29
00884450022313One-Step™DOSC-5F-10LT2026-07-29
00884450022535One-Step™DOSC-5F-7LT2026-07-29
00884450022559One-Step™DOSC-5F-10S2026-07-29
00884450022566One-Step™DOSC-5F-7S2026-07-29
00884450022573One-Step™DOSC-4F-10L2026-07-29
00884450022597One-Step™DOSC-4F-10LNH2026-07-29
00884450022603One-Step™DOSC-4F-7L2026-07-29
00884450022665One-Step™DOSC-4F-7S2026-07-29
00884450022689One-Step™DOSC-5F-10LNH2026-07-29
00884450022764One-Step™DOSC-5F-7L2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450498996Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-30
10809160528150HalyardAVID MEDICAL, INC.OEZ2026-07-30
10809160528167HalyardAVID MEDICAL, INC.OEZ2026-07-30
00884450431672Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-29
10809160528020HalyardAVID MEDICAL, INC.OEZ2026-07-28
10198956423527CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956442191CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956459830CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956466388CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956466890CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956477131CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956478893CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956482449CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956493605CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956494770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956496187CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956499379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956504684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956505131CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956505674CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956514188CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956516298CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956516878CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956518742CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956520684CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956521513CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956521643CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956521667CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956524163CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27
10198956524293CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-27