FDA.report

Merit Medical®

Primary DI
20884450555877
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450555873
Catalog number
K09-12174A
Published
2021-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OEQAngiography/angioplasty kit
OEZCardiovascular procedure kit

Product Code Classifications

CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450555870PackageGS16In Commercial Distribution
20884450555877PackageGS12In Commercial Distribution
00884450555873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445055587010884450555870
2088445055587720884450555877
00884450555873008844505558738844505558730884450555873

GMDN Terms

TermDefinition
Contrast medium injection system administration setA collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer; it is typically made of plastic materials. This is a disposable device which may serve multiple patients before being discarded.

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
10809160521816HalyardAVID MEDICAL, INC.OEZ2026-05-26
10809160521823HalyardAVID MEDICAL, INC.OEZ2026-05-26
10198956359949CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956377790CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956378254CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956382701CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956421394CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956422308CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956439337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956442405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956443716CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956453203CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956459359CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956460485CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956466333CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956466968CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956470170CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956473164CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956480582CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956480827CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956481770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484153CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484542CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956484610CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956485211CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956486478CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486669CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486768CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-05-25
10198956486829CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25