FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450851463
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K12T-12562
Published
2025-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00884450851463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450851463008844508514638844508514630884450851463

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound/centesis drainage receptacleA sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.

Sterilization Methods#

Method table
Method

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
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