FDA.reportPublic FDA data

Fountain®

Primary DI
10884450826239
Brand
Fountain®
Company
Merit Medical Systems, Inc.
Model
B
Catalog number
FIS5-135-50SQ
Published
2025-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QEYMechanical thrombolysis catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEYMechanical Thrombolysis CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450826239PackageGS15In Commercial Distribution
00884450826232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445082623910884450826239
00884450826232008844508262328844508262320884450826232

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00884450108765Merit Medical®Initial ReleaseK09-10721A2026-07-10
00884450450949Merit Medical®Initial ReleaseK09-143532026-07-11
00884450487334Merit Medical®Initial ReleaseK11-014852026-07-10
00884450487341Merit Medical®Initial ReleaseK12-127232026-07-10
00884450492956Merit Medical®Initial ReleaseK10T-061782026-07-11
00884450486436Merit Medical®Initial ReleaseK09-144172026-07-09
00884450488812Merit Medical®Initial ReleaseK17-00021A2026-07-09
00884450437698Merit Medical®Initial ReleaseK09-09854C2026-07-08
00884450468913DuraMax®CH7871030280252026-07-08
00884450487273Merit Medical®Initial ReleaseK12T-02285H2026-07-08
00884450846254Flex-Neck®CCF-52602026-07-08
10884450415631Prelude®JPSI-6F-11-0252026-07-08
10884450415655Prelude®JPSI-6F-11-035-18G2026-07-08
10884450707781Prelude®FPSI-6F-11-0252026-07-08
10884450831554Tru-Cut®C2N2713X2026-07-08
00884450467039Merit Medical®Initial ReleaseK10T-03350D2026-07-07
00884450475812Merit Medical®Initial ReleaseK09-144032026-07-07
00884450486443Merit Medical®Initial ReleaseK09-143402026-07-07
00884450529348SplashWire™Initial ReleaseMSWSTFS381502026-07-07
00884450423790Merit Medical®Initial ReleaseK09-10667B2026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450825969Fountain®Merit Medical Systems, Inc.QEY2026-06-24
00884450826171Fountain®Merit Medical Systems, Inc.QEY2026-03-21
00884450826355Fountain®Merit Medical Systems, Inc.QEY2026-02-21
00884450826225Fountain®Merit Medical Systems, Inc.QEY2026-02-18
00884450826188Fountain®Merit Medical Systems, Inc.QEY2026-01-29
00884450826201Fountain®Merit Medical Systems, Inc.QEY2026-01-16
00884450826331Fountain®Merit Medical Systems, Inc.QEY2026-01-06
10884450826338Fountain®Merit Medical Systems, Inc.QEY2026-01-06
00884450825983Fountain®Merit Medical Systems, Inc.QEY2025-12-03
10884450825980Fountain®Merit Medical Systems, Inc.QEY2025-12-03
00884450825976Fountain®Merit Medical Systems, Inc.QEY2025-11-27
10884450825973Fountain®Merit Medical Systems, Inc.QEY2025-11-27
00884450826232Fountain®Merit Medical Systems, Inc.QEY2025-11-12
00884450825761Fountain®Merit Medical Systems, Inc.QEY2025-10-15
00884450826072Fountain®Merit Medical Systems, Inc.QEY2025-08-05
10884450826079Fountain®Merit Medical Systems, Inc.QEY2025-08-05
00884450825945Fountain®Merit Medical Systems, Inc.QEY2025-05-31
10884450825942Fountain®Merit Medical Systems, Inc.QEY2025-05-31
00884450825990Fountain®Merit Medical Systems, Inc.QEY2025-05-16
00884450825549Fountain®Merit Medical Systems, Inc.QEY2025-05-13
00884450825914Fountain®Merit Medical Systems, Inc.QEY2025-05-13
10884450825911Fountain®Merit Medical Systems, Inc.QEY2025-05-13
00884450826195Fountain®Merit Medical Systems, Inc.QEY2025-03-18
10884450826192Fountain®Merit Medical Systems, Inc.QEY2025-03-18
00884450826607Fountain®Merit Medical Systems, Inc.QEY2025-03-15
10884450826604Fountain®Merit Medical Systems, Inc.QEY2025-03-15
00884450826126Fountain®Merit Medical Systems, Inc.QEY2025-02-20
10884450826123Fountain®Merit Medical Systems, Inc.QEY2025-02-20
00884450826409Fountain®Merit Medical Systems, Inc.QEY2025-02-14
10884450826406Fountain®Merit Medical Systems, Inc.QEY2025-02-14