FDA.report

Fountain®

Primary DI
10884450825973
Brand
Fountain®
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
FIS4-135-50SQ
Published
2025-11-27
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

Related Records

Product Codes

CodeName
QEYMechanical thrombolysis catheter

Product Code Classifications

CodeDeviceSpecialtyClass
QEYMechanical Thrombolysis CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450825973PackageGS15In Commercial Distribution
00884450825976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445082597310884450825973
00884450825976008844508259768844508259760884450825976

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

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

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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
10884450826338Fountain®Merit Medical Systems, Inc.QEY2026-01-06
10884450825980Fountain®Merit Medical Systems, Inc.QEY2025-12-03
10884450826239Fountain®Merit Medical Systems, Inc.QEY2025-11-12
10884450826079Fountain®Merit Medical Systems, Inc.QEY2025-08-05
10884450825942Fountain®Merit Medical Systems, Inc.QEY2025-05-31
10884450825911Fountain®Merit Medical Systems, Inc.QEY2025-05-13
10884450826192Fountain®Merit Medical Systems, Inc.QEY2025-03-18
10884450826604Fountain®Merit Medical Systems, Inc.QEY2025-03-15
10884450826123Fountain®Merit Medical Systems, Inc.QEY2025-02-20
10884450826406Fountain®Merit Medical Systems, Inc.QEY2025-02-14
10884450826284Fountain®Merit Medical Systems, Inc.QEY2024-12-20
10850005115080BASHIR™ S-B .035 Endovascular CatheterTHROMBOLEX, INC.QEY2023-12-11
00191506013721EKOS™BOSTON SCIENTIFIC CORPORATIONQEY2023-05-10
00191506013738EKOS™BOSTON SCIENTIFIC CORPORATIONQEY2023-05-10
00850016840134EKOS™BOSTON SCIENTIFIC CORPORATIONQEY2023-05-10
00850016840172EKOS™BOSTON SCIENTIFIC CORPORATIONQEY2023-05-10
00850005115021Bashir™ S-B Endovascular Catheter 7Fr, 10.0cm basketTHROMBOLEX, INC.QEY2020-02-17
00850005115038Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm InfusionTHROMBOLEX, INC.QEY2020-02-17
00850005115045Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 20.0cm InfusionTHROMBOLEX, INC.QEY2020-02-17
00850005115052Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 30.0cm InfusionTHROMBOLEX, INC.QEY2020-02-17
00850005115069Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 40.0cm InfusionTHROMBOLEX, INC.QEY2020-02-17
00850005115007Bashir™ Endovascular CatheterTHROMBOLEX, INC.QEY2019-04-10
10884450045913Squirt®Merit Medical Systems, Inc.QEY2016-09-24
H787128002015SpeedLyserANGIODYNAMICS, INC.QEY2016-09-21
H787128002025SpeedLyserANGIODYNAMICS, INC.QEY2016-09-21
H787128002045SpeedLyserANGIODYNAMICS, INC.QEY2016-09-21