FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450047903
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450047903
Catalog number
K09-08324
Published
2018-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10884450047900PackageGS115In Commercial Distribution
20884450047907PackageGS14In Commercial Distribution
00884450047903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445004790010884450047900
2088445004790720884450047907
00884450047903008844500479038844500479030884450047903

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
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450031131Merit Medical®Initial ReleaseK08-02653A2026-05-28
00884450392850SCOUT MD™Initial ReleaseMDS05A-012026-05-28
00884450392867SCOUT MD™Initial ReleaseMDS05B-012026-05-28
00884450392874SCOUT MD™Initial ReleaseMDS05C-012026-05-28
00884450392881SCOUT MD™Initial ReleaseMDS05M-012026-05-28
00884450392935SCOUT MD™Initial ReleaseMDS75A-012026-05-28
00884450392942SCOUT MD™Initial ReleaseMDS75B-012026-05-28
00884450392959SCOUT MD™Initial ReleaseMDS75C-012026-05-28
00884450392966SCOUT MD™Initial ReleaseMDS75M-012026-05-28
00884450428313Merit Medical®Initial ReleaseK09-09671B2026-05-28
00884450430057Merit Medical®Initial ReleaseK12-01244B2026-05-28
00884450487532Merit Medical®Initial ReleaseK09T-136472026-05-28
00884450487549Merit Medical®Initial ReleaseK12T-11710A2026-05-28
00884450487679Merit Medical®Initial ReleaseK10T-06195A2026-05-28
00884450766958Performa®B1623-F820M2026-05-28
10884450415358Prelude®JPSI-4F-23MT2026-05-28
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450428313Merit Medical®Merit Medical Systems, Inc.OEZ2026-05-28
00884450487532Merit Medical®Merit Medical Systems, Inc.OEZ2026-05-28
10809160522042HalyardAVID MEDICAL, INC.OEZ2026-05-28
10809160522066HalyardAVID MEDICAL, INC.OEZ2026-05-28
10809160522097HalyardAVID MEDICAL, INC.OEZ2026-05-28
10809160521984HalyardAVID MEDICAL, INC.OEZ2026-05-27
H65857031555Henry ScheinHENRY SCHEIN, INC.OEZ2022-08-25
H65857031565Henry ScheinHENRY SCHEIN, INC.OEZ2022-08-25
H65857031315Henry ScheinHENRY SCHEIN, INC.OEZ2022-08-10
H65857030865Henry ScheinHENRY SCHEIN, INC.OEZ2022-05-25
H65857029425Henry ScheinHENRY SCHEIN, INC.OEZ2022-03-31
H65857029535Henry ScheinHENRY SCHEIN, INC.OEZ2022-03-31
10193489040166NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040180NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040197NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040203NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040210NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040227NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040234NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040241NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040258NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040265NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040272NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040289NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040296NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040302NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040319NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040326NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040333NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040340NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28