FDA.reportPublic FDA data

Merit Medical®

Primary DI
20884450837911
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K15-00429
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
OEXCardiovascular catheter sheath introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEXCardiovascular Catheter Sheath Introducer KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450837914PackageGS15In Commercial Distribution
20884450837911PackageGS14In Commercial Distribution
00884450837917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445083791410884450837914
2088445083791120884450837911
00884450837917008844508379178844508379170884450837917

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00884450467572DuraMax®CH7871030281952026-06-08
00884450469033BioFlo DuraMax®BH9651030281612026-06-08
00884450469132BioFlo DuraMax®BH9651030282112026-06-08
00884450787663Impress®C44038STS2026-06-08
10884450114855Prelude IDeal™HPID5F16021PW2026-06-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450837917Merit Medical®Merit Medical Systems, Inc.OEX2025-05-31
00884450760901Merit Medical®Merit Medical Systems, Inc.OEX2023-07-27
00884450760918Merit Medical®Merit Medical Systems, Inc.OEX2023-07-27
20884450760905Merit Medical®Merit Medical Systems, Inc.OEX2023-07-27
20884450760912Merit Medical®Merit Medical Systems, Inc.OEX2023-07-27
20884450525191COBRA-OSMerit Medical Systems, Inc.OEX2022-05-19
10195594227432CARDINAL HEALTHCardinal Health 200, LLCOEX2021-11-12
50195594227430CARDINAL HEALTHCardinal Health 200, LLCOEX2021-11-12
10884450565930Merit Medical®Merit Medical Systems, Inc.OEX2021-04-08
00884450432051Merit Medical®Merit Medical Systems, Inc.OEX2021-03-27
10884450432058Merit Medical®Merit Medical Systems, Inc.OEX2021-03-27
00884450534359Merit Medical®Merit Medical Systems, Inc.OEX2021-01-19
10884450534356Merit Medical®Merit Medical Systems, Inc.OEX2021-01-19
00884450537817Merit Medical®Merit Medical Systems, Inc.OEX2021-01-14
10884450537814Merit Medical®Merit Medical Systems, Inc.OEX2021-01-14
00884450530702Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2021-01-12
10884450530709Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2021-01-12
00884450527030Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2021-01-08
20884450527034Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2021-01-08
00884450532768Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-12-08
20884450532762Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-12-08
00884450532799Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-11-17
10884450532796Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-11-17
00884450524329Merit Medical®Merit Medical Systems, Inc.OEX2020-10-21
20884450524323Merit Medical®Merit Medical Systems, Inc.OEX2020-10-21
00884450505113Merit Medical®Merit Medical Systems, Inc.OEX2020-09-03
10884450505110Merit Medical®Merit Medical Systems, Inc.OEX2020-09-03
00884450505106Merit Medical®Merit Medical Systems, Inc.OEX2020-08-27
10884450505103Merit Medical®Merit Medical Systems, Inc.OEX2020-08-27
00884450485286Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-07-08