FDA.reportPublic FDA data

Fountain®

Primary DI
10884450826079
Brand
Fountain®
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
FIS4-90-30
Published
2025-08-05
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
10884450826079PackageGS15In Commercial Distribution
00884450826072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445082607910884450826079
00884450826072008844508260728844508260720884450826072

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
00884450161692Merit Medical®Initial ReleaseK09-10791D2026-10-22
00884450428238Merit Medical®Initial ReleaseK10-00125M2026-10-22
00884450435700Merit Medical®Initial ReleaseK10-04943A2026-10-22
00884450499214Merit Medical®Initial ReleaseK12T-02975G2026-10-22
00884450501023Merit Medical®Initial ReleaseK12T-127572026-10-22
00884450501047Merit Medical®Initial ReleaseK10-06118G2026-10-22
00884450501054Merit Medical®Initial ReleaseK09-05248Q2026-10-22
00884450501078Merit Medical®Initial ReleaseK10-00389R2026-10-22
00884450501085Merit Medical®Initial ReleaseK09-14184F2026-10-22
00884450502075Merit Medical®Initial ReleaseK10-03143F2026-10-22
00884450502082Merit Medical®Initial ReleaseK12T-09122J2026-10-22
00884450502556Merit Medical®Initial ReleaseK09-144532026-10-22
00884450502891Merit Medical®Initial ReleaseK09-05181J2026-10-22
00884450502921Merit Medical®Initial ReleaseK09-12476F2026-10-22
00884450502938Merit Medical®Initial ReleaseK09-14208C2026-10-22
00884450502952Merit Medical®Initial ReleaseK09-10938F2026-10-22
00884450502969Merit Medical®Initial ReleaseK09-13923C2026-10-22
10884450485672EndoAVF® Access KitInitial ReleaseK21-000922026-10-22
00884450420065Merit Medical®Initial ReleaseK09-14003B2026-10-21
00884450431641Merit Medical®Initial ReleaseK12-11132C2026-10-21

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
10884450826239Fountain®Merit Medical Systems, Inc.QEY2025-11-12
00884450825761Fountain®Merit Medical Systems, Inc.QEY2025-10-15
00884450826072Fountain®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