FDA.reportPublic FDA data

Monarch®

Primary DI
10884450236311
Brand
Monarch®
Company
Merit Medical Systems, Inc.
Model
00884450236314
Catalog number
K05-01290G
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
10884450236311PackageGS132In Commercial Distribution
00884450236314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445023631110884450236311
00884450236314008844502363148844502363140884450236314

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
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
00884450277652Safety Paracentesis Procedure TrayInitial ReleaseSPPT-8F-10S2026-09-22
00884450416723SureCrossDSC18652026-09-22
00884450422755SureCrossDSC14902026-09-22
00884450423110SureCrossDSC14652026-09-22
00884450427170SureCrossDSC141352026-09-22
00884450428016Merit Medical®Initial ReleaseK10-03360H2026-09-22
00884450435526Merit Medical®Initial ReleaseK09-11159A2026-09-22
00884450445419Merit Medical®Initial ReleaseK09-01589X2026-09-22
00884450473313Merit Medical®Initial ReleaseK09-14357A2026-09-22
00884450852279Merit Medical®Initial ReleasePC8112026-09-22
00884450852286Merit Medical®Initial ReleasePC8122026-09-22
10884450489809Prelude SNAP™APLSX-25112026-09-22
10884450489816Prelude SNAP™APLSS-10062026-09-22
10884450489823Prelude SNAP™APLSS-10072026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956439849CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956512177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956545991CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956551657CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956556454CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956567948CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956579316CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956581838CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956582293CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956583931CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956586208CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956587342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956588691CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956588882CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956588998CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589025CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589230CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589261CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589377CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589421CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956589544CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956592605CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956339255CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956504271CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956571013CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956571174CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956577664CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956581869CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956581906CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22
10198956582149CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-22