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
00884450031131Merit Medical®Initial ReleaseK08-02653A2026-05-28
00884450392850SCOUT MD™Initial ReleaseMDS05A-012026-05-28
00884450392867SCOUT MD™Initial ReleaseMDS05B-012026-05-28
00884450392874SCOUT MD™Initial ReleaseMDS05C-012026-05-28
00884450392881SCOUT MD™Initial ReleaseMDS05M-012026-05-28
00884450392935SCOUT MD™Initial ReleaseMDS75A-012026-05-28
00884450392942SCOUT MD™Initial ReleaseMDS75B-012026-05-28
00884450392959SCOUT MD™Initial ReleaseMDS75C-012026-05-28
00884450392966SCOUT MD™Initial ReleaseMDS75M-012026-05-28
00884450428313Merit Medical®Initial ReleaseK09-09671B2026-05-28
00884450430057Merit Medical®Initial ReleaseK12-01244B2026-05-28
00884450487532Merit Medical®Initial ReleaseK09T-136472026-05-28
00884450487549Merit Medical®Initial ReleaseK12T-11710A2026-05-28
00884450487679Merit Medical®Initial ReleaseK10T-06195A2026-05-28
00884450766958Performa®B1623-F820M2026-05-28
10884450415358Prelude®JPSI-4F-23MT2026-05-28
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

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
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
00884450826454Fountain®Merit Medical Systems, Inc.QEY2025-02-05