FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450426340
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450426340
Published
2019-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCYBulb, inflation, for endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCYBulb, Inflation, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450426347PackageGS15In Commercial Distribution
20884450426344PackageGS15In Commercial Distribution
00884450426340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445042634710884450426347
2088445042634420884450426344
00884450426340008844504263408844504263400884450426340

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis catheter introduction setA collection of sterile devices, which includes at least one invasive device, intended to assist percutaneous placement of a peritoneal dialysis catheter (not included). The kit includes devices intended to assist catheter insertion (e.g., dilators, insertion sheath) and may include additional non-dedicated catheterization support devices (e.g., dressings); it does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
184763290
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450014523ReSolve®, StayFIX®,ARLCMB-NV-10-SFX2026-07-16
00884450161777Merit Medical®Initial ReleaseK09-10897B2026-07-16
00884450432075Merit Medical®Initial ReleaseK11-01125B2026-07-16
00884450434482Merit Medical®Initial ReleaseK10-05031A2026-07-14
00884450493182Merit Medical®Initial ReleaseK09-09809C2026-07-14
00884450493199Merit Medical®Initial ReleaseK11-014882026-07-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995360191NAMEDIVATORS INC.FCY2026-02-04
00724995360207NAMEDIVATORS INC.FCY2026-02-04
00724995360214NAMEDIVATORS INC.FCY2026-02-04
00724995360221NAMEDIVATORS INC.FCY2026-02-04
00724995360238NAMEDIVATORS INC.FCY2026-02-04
00724995360245NAMEDIVATORS INC.FCY2026-02-04
00816185001127Dovideq LeakControl DeviceTorvan Medical IncFCY2025-09-18
00724995244415NAMEDIVATORS INC.FCY2025-06-10
00724995244422NAMEDIVATORS INC.FCY2025-06-10
00724995244439NAMEDIVATORS INC.FCY2025-06-10
00724995244446NAMEDIVATORS INC.FCY2025-06-10
00724995244453NAMEDIVATORS INC.FCY2025-06-10
00724995244460NAMEDIVATORS INC.FCY2025-06-10
00724995244477NAMEDIVATORS INC.FCY2025-06-10
00724995244484NAMEDIVATORS INC.FCY2025-06-10
00724995244491NAMEDIVATORS INC.FCY2025-06-10
50724995244410NAMEDIVATORS INC.FCY2025-06-10
50724995244427NAMEDIVATORS INC.FCY2025-06-10
50724995244434NAMEDIVATORS INC.FCY2025-06-10
50724995244441NAMEDIVATORS INC.FCY2025-06-10
50724995244458NAMEDIVATORS INC.FCY2025-06-10
50724995244465NAMEDIVATORS INC.FCY2025-06-10
50724995244472NAMEDIVATORS INC.FCY2025-06-10
50724995244489NAMEDIVATORS INC.FCY2025-06-10
50724995244496NAMEDIVATORS INC.FCY2025-06-10
00816185001141AutoSink with Endoscope Leak TesterTorvan Medical IncFCY2025-04-28
00816185001158LT Connector 1OTorvan Medical IncFCY2025-04-28
06971919462156noneNingbo Albert Novosino Co.,Ltd.FCY2025-03-14
04048551054901n.a.Karl Storz GmbH & Co. KGFCY2024-11-29
04055207070055NARichard Wolf GmbHFCY2024-06-03