FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450413835
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450413838
Catalog number
K05-03125
Published
2019-09-18
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
10884450413835PackageGS15In Commercial Distribution
20884450413832PackageGS14In Commercial Distribution
00884450413838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445041383510884450413835
2088445041383220884450413832
00884450413838008844504138388844504138380884450413838

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
true
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
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
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956378254CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956421394CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956422308CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956460485CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956466968CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956473164CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956484542CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486478CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486669CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486768CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956488267CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956490567CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
00884450474587Merit Medical®Merit Medical Systems, Inc.OEQ2026-05-23
00884450220696Merit Medical®Merit Medical Systems, Inc.OEQ2026-03-24
50198956300499CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956339840CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956418514CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956421804CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956431957CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956274721CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956325331CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956332872CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956337969CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956339918CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956341508CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956343342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956346541CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956353211CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956353488CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956359466CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23