FDA.reportPublic FDA data

Monarch®

Primary DI
20884450236875
Brand
Monarch®
Company
Merit Medical Systems, Inc.
Model
00884450236871
Catalog number
K05-00787B
Published
2018-09-13
Public version status
Update
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450236878PackageGS15In Commercial Distribution
20884450236875PackageGS14In Commercial Distribution
00884450236871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445023687810884450236878
2088445023687520884450236875
00884450236871008844502368718844502368710884450236871

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. 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
00884450486436Merit Medical®Initial ReleaseK09-144172026-07-09
00884450488812Merit Medical®Initial ReleaseK17-00021A2026-07-09
00884450437698Merit Medical®Initial ReleaseK09-09854C2026-07-08
00884450468913DuraMax®CH7871030280252026-07-08
00884450487273Merit Medical®Initial ReleaseK12T-02285H2026-07-08
00884450846254Flex-Neck®CCF-52602026-07-08
10884450415631Prelude®JPSI-6F-11-0252026-07-08
10884450415655Prelude®JPSI-6F-11-035-18G2026-07-08
10884450707781Prelude®FPSI-6F-11-0252026-07-08
10884450831554Tru-Cut®C2N2713X2026-07-08
00884450467039Merit Medical®Initial ReleaseK10T-03350D2026-07-07
00884450475812Merit Medical®Initial ReleaseK09-144032026-07-07
00884450486443Merit Medical®Initial ReleaseK09-143402026-07-07
00884450529348SplashWire™Initial ReleaseMSWSTFS381502026-07-07
00884450423790Merit Medical®Initial ReleaseK09-10667B2026-07-03
00884450438480Merit Medical®Initial ReleaseK10-03045C2026-07-03
00884450486337Merit Medical®Initial ReleaseK10T-062082026-07-03
00884450475805Merit Medical®Initial ReleaseK12T-05568F2026-06-27
00884450492864Merit Medical®Initial ReleaseK12T-05833B2026-06-27
00884450436202Merit Medical®Initial ReleaseK10-05785A2026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956307308CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956349834CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956368163CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956470897CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956483651CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956485143CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956491588CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956499959CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956504035CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956517752CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956521650CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956524750CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956525580CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956525832CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956526174CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956527249CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956527645CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956527744CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956528086CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956528222CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956528246CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
00884450487273Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-08
10198956373655CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956416482CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956514119CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956515789CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956516083CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956517844CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956518025CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956520301CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06