FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450251918
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450251911
Catalog number
K09-12340
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
10884450251918PackageGS110In Commercial Distribution
20884450251915PackageGS14In Commercial Distribution
00884450251911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445025191810884450251918
2088445025191520884450251915
00884450251911008844502519118844502519110884450251911

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
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