FDA.report

Merit Medical®

Primary DI
20884450595149
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450595145
Catalog number
K09-13794
Published
2021-09-14
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

Related Records

Product Codes

CodeName
OEZCardiovascular procedure kit

Product Code Classifications

CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450595142PackageGS110In Commercial Distribution
20884450595149PackageGS14In Commercial Distribution
00884450595145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445059514210884450595142
2088445059514920884450595149
00884450595145008844505951458844505951450884450595145

GMDN Terms

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.

Sterilization Methods

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 DIBrandModelCatalogPublished
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24
10884450845223Merit Medical®D3339-312026-03-24
10884450027339Merit Medical®Initial ReleaseK04-01029A2026-03-20
10884450112721Merit Medical®Initial ReleaseK09-10994G2026-03-21
20884450164918Merit Medical®Initial ReleaseK09-12174B2026-03-21
10884450428532Merit Medical®Initial ReleaseK09-09762A2026-03-21
10884450430788Merit Medical®Initial ReleaseK10-05773A2026-03-21
10884450430856Merit Medical®Initial ReleaseK09-04213A2026-03-21
10884450440602Merit Medical®Initial ReleaseK09-11433M2026-03-21
20884450441514Merit Medical®Initial ReleaseK09-14148B2026-03-21
20884450441552Merit Medical®Initial ReleaseK12-12053B2026-03-21
10884450441784SteadySheath®BLR-TSS-13.02026-03-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00191072241948ACSAMERICAN CONTRACT SYSTEMS, INC.OEZ2026-03-24
00191072241962ACSAMERICAN CONTRACT SYSTEMS, INC.OEZ2026-03-24
10884450111731Merit Medical®Merit Medical Systems, Inc.OEZ2026-03-24
10884450423629Merit Medical®Merit Medical Systems, Inc.OEZ2026-03-24
20884450430815Merit Medical®Merit Medical Systems, Inc.OEZ2026-03-24
10884450430863Merit Medical®Merit Medical Systems, Inc.OEZ2026-03-24
50198956220643CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956311372CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956328851CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956338218CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956345469CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956348736CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956366365CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956398427CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956406139CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956419757CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956419955CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956420821CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956423686CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956425574CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956425673CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956426540CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956426649CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956427004CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956427318CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956427349CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956427363CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-24
50198956116885CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-23
50198956187861CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-23
50198956197105CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-03-23