FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450155554
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450155554
Catalog number
K02-00565C
Published
2018-09-13
Public version status
New
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450155551PackageGS110In Commercial Distribution
20884450155558PackageGS14In Commercial Distribution
00884450155554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445015555110884450155551
2088445015555820884450155558
00884450155554008844501555548844501555540884450155554

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

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
00884450433812Merit Medical®Initial ReleaseK08-02803A2026-07-23
00884450485163Merit Medical®Initial ReleaseK12T-11888B2026-07-23
00884450376546Merit Medical®Initial ReleaseK09-05229L2026-07-22
00884450431764Merit Medical®Initial ReleaseK10-04836A2026-07-22
00884450488751Merit Medical®Initial ReleaseK09-144102026-07-22
00884450492888Merit Medical®Initial ReleaseK01-08008A2026-07-22
00884450499276Merit Medical®Initial ReleaseK09-13679B2026-07-22
00884450421581Merit Medical®Initial ReleaseK12-08733A2026-07-21
00884450795705Merit Medical®Initial ReleaseK12-10248A2026-07-21
00884450457382C2 CryoBalloon™AFG-10132026-07-20
00884450163344Merit Medical®Initial ReleaseK09-11661B2026-07-18
00884450486627Merit Medical®Initial ReleaseK12T-09218A2026-07-18
00884450486641Merit Medical®Initial ReleaseK12T-127262026-07-17
00884450486849Merit Medical®Initial ReleaseK12T-127272026-07-17
10884450708955Prelude®FPSI-8F-11-035-18G2026-07-18
00884450014523ReSolve®, StayFIX®,ARLCMB-NV-10-SFX2026-07-16
00884450161777Merit Medical®Initial ReleaseK09-10897B2026-07-16
00884450432075Merit Medical®Initial ReleaseK11-01125B2026-07-16
00884450434482Merit Medical®Initial ReleaseK10-05031A2026-07-14
00884450493182Merit Medical®Initial ReleaseK09-09809C2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450485163Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-23
B098AMS191180Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-07-22
00884450421581Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-21
10198956443013CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956462717CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956469075CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956488793CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956490192CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956493551CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956497207CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956499409CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956510715CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956514966CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956518605CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956520653CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956527355CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528543CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528567CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528635CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528802CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528949CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956529731CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956530829CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956531185CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956531758CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956531895CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956532687CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956532731CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956532823CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956533479CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20