FDA.reportPublic FDA data

Fountain®

Primary DI
10884450825942
Brand
Fountain®
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
FIS4-135-40SQ
Published
2025-05-31
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
10884450825942PackageGS15In Commercial Distribution
00884450825945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445082594210884450825942
00884450825945008844508259458844508259450884450825945

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
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06
00884450436745Merit Medical®Initial ReleaseK09-13832A2026-06-06
00884450220306Merit Medical®Initial ReleaseK12-126952026-06-03
00884450426630Merit Medical®Initial ReleaseK09-13283C2026-06-03
00884450437438Merit Medical®Initial ReleaseK09-14187A2026-06-03
00884450485651Merit Medical®Initial ReleaseK04-00404B2026-06-03
00884450486887Merit Medical®Initial ReleaseK09-07789R2026-06-03
00884450487006Merit Medical®Initial ReleaseK12-127222026-06-03
10884450706708Prelude®FPSI-4F-23-035MT2026-06-03
00884450424087Merit Medical®Initial ReleaseK09-13251A2026-06-02
00884450431009Merit Medical®Initial ReleaseK08-03026A2026-06-02
00884450435403Merit Medical®Initial ReleaseK09-11196A2026-06-02
00884450457511C2 CryoBalloon™AFG-10242026-06-02
00884450457528C2 CryoBalloon™AFG-10282026-06-02
00884450457566C2 CryoBalloon™AFG-10552026-06-02
00884450457573C2 CryoBalloon™AFG-10562026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10884450826239Fountain®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
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
00884450826454Fountain®Merit Medical Systems, Inc.QEY2025-02-05