FDA.reportPublic FDA data

Merit Medical®

Primary DI
20884450249318
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450249314
Catalog number
K09-08790C
Published
2018-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10884450249311PackageGS110In Commercial Distribution
20884450249318PackageGS14In Commercial Distribution
00884450249314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445024931110884450249311
2088445024931820884450249318
00884450249314008844502493148844502493140884450249314

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium injection system manifold kitA collection of sterile devices designed to provide an interface between a contrast medium injection system and an angiographic patient catheter for the delivery of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It is intended to maximize the creation of the optimal connection for fluid delivery. It typically consists of an injection fitting that is connected to the contrast medium injection system, a pressure transducer cartridge, a check valve and tubing; it is typically made of plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

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
00884450029756Merit Medical®Initial ReleaseK08-02280A2026-09-29
00884450421383Merit Medical®Initial ReleaseK09-09424A2026-09-29
00884450431917Merit Medical®Initial ReleaseK09-13874B2026-09-29
00884450436004Merit Medical®Initial ReleaseK12-05438A2026-09-29
00884450452974MAK-NV™DMAK-NV-0082026-09-29
00884450453339MAK-NV™DMAK-NV-0162026-09-29
00884450500002Merit Medical®Initial ReleaseK09-144152026-09-29
10884450119751Prelude EASE™JPHR6F11018SC2026-09-29
10884450280055Prelude®JPSI-4F-11-0182026-09-29
10884450415839Prelude®JPSI-7F-11-0182026-09-29
10884450439163Prelude IDeal™JPID6F11021SSC2026-09-29
10884450439187Prelude IDeal™JPID6F11021PW2026-09-29
10884450452353STAR™FRF-0510L-012026-09-29
10884450831547Tru-Cut®C2N2712X2026-09-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956587298CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-01
10809160539569HalyardAVID MEDICAL, INC.OEZ2026-10-01
10197106980361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956485105CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956563247CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956565913CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956568167CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956575745CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956578999CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956589209CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956590083CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592285CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592599CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592636CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592704CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592810CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956593688CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956593961CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956594623CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956595255CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956596078CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956596153CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956598225CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10809160539392HALYARDAVID MEDICAL, INC.OEZ2026-09-30
10809160539408HalyardAVID MEDICAL, INC.OEZ2026-09-30
10809160539460HalyardAVID MEDICAL, INC.OEZ2026-09-30
10809160539484HalyardAVID MEDICAL, INC.OEZ2026-09-30
00884450421383Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-29
00884450431917Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-29
00884450500002Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-29