FDA.report

Merit Medical®

Primary DI
10884450537814
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450537817
Catalog number
K15-00401
Published
2021-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OEXCardiovascular catheter sheath introducer kit

Product Code Classifications

CodeDeviceSpecialtyClass
OEXCardiovascular Catheter Sheath Introducer KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450537814PackageGS15In Commercial Distribution
20884450537811PackageGS14In Commercial Distribution
00884450537817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445053781410884450537814
2088445053781120884450537811
00884450537817008844505378178844505378170884450537817

GMDN Terms

TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, 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

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 DIBrandModelCatalogPublished
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24
10884450845223Merit Medical®D3339-312026-03-24
10884450027339Merit Medical®Initial ReleaseK04-01029A2026-03-20
10884450112721Merit Medical®Initial ReleaseK09-10994G2026-03-21
20884450164918Merit Medical®Initial ReleaseK09-12174B2026-03-21
10884450428532Merit Medical®Initial ReleaseK09-09762A2026-03-21
10884450430788Merit Medical®Initial ReleaseK10-05773A2026-03-21
10884450430856Merit Medical®Initial ReleaseK09-04213A2026-03-21
10884450440602Merit Medical®Initial ReleaseK09-11433M2026-03-21
20884450441514Merit Medical®Initial ReleaseK09-14148B2026-03-21
20884450441552Merit Medical®Initial ReleaseK12-12053B2026-03-21
10884450441784SteadySheath®BLR-TSS-13.02026-03-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20884450837911Merit Medical®Merit Medical Systems, Inc.OEX2025-05-31
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
50195594227430CARDINAL HEALTHCardinal Health 200, LLCOEX2021-11-12
10884450565930Merit Medical®Merit Medical Systems, Inc.OEX2021-04-08
10884450432058Merit Medical®Merit Medical Systems, Inc.OEX2021-03-27
10884450534356Merit Medical®Merit Medical Systems, Inc.OEX2021-01-19
10884450530709Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2021-01-12
20884450527034Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2021-01-08
20884450532762Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-12-08
10884450532796Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-11-17
20884450524323Merit Medical®Merit Medical Systems, Inc.OEX2020-10-21
10884450505110Merit Medical®Merit Medical Systems, Inc.OEX2020-09-03
10884450505103Merit Medical®Merit Medical Systems, Inc.OEX2020-08-27
10884450485283Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-07-08
20884450474093Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-06-11
20884450480681Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-05-13
20884450409545Merit Medical®Merit Medical Systems, Inc.OEX2020-05-05
10884450482671Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-04-23
10884450482954Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-04-23
20884450482944Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-04-17
20884450475649Merit Medical®Merit Medical Systems, Inc.OEX2020-02-25
20884450476080Merit Medical®Merit Medical Systems, Inc.OEX2020-02-25
10884450476908Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-02-25
10884450476915Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-02-24
20884450474062Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-02-19
20884450474079Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-02-19
20884450474086Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-02-19
10884450465322Prelude IDeal™ Hydrophilic SheathMerit Medical Systems, Inc.OEX2020-01-13