FDA.reportPublic FDA data

Prelude®

Primary DI
10884450706708
Brand
Prelude®
Company
Merit Medical Systems, Inc.
Model
F
Catalog number
PSI-4F-23-035MT
Published
2026-06-03
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
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450706705PackageGS14In Commercial Distribution
10884450706708PrimaryGS10
00884450706701Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445070670520884450706705
1088445070670810884450706708
00884450706701008844507067018844507067010884450706701

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
184763290
Device count
5
DM exempt
false
Premarket exempt
false
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
00884450421994Merit Medical®Initial ReleaseK12-12513B2026-08-01
00884450447093Merit Medical®Initial ReleaseK09-02692J2026-08-01
00884450468951DuraMax®CH7871030282012026-07-31
00884450500927Merit Medical®Initial ReleaseK12T-02563D2026-08-01
00884450838136Prelude Roadster™APG6F45R2026-07-31
00884450117156Merit Medical®Initial ReleaseK12T-03663D2026-07-30
00884450486191Merit Medical®Initial ReleaseK12T-12644C2026-07-30
00884450486207Merit Medical®Initial ReleaseK12T-12645C2026-07-30
00884450498996Merit Medical®Initial ReleaseK09-143912026-07-30
00884450499207Merit Medical®Initial ReleaseK10T-01528J2026-07-30
00884450587713StabiliT®DDF-5000A2026-07-30
00884450022146One-Step™DOSC-4F-10LT2026-07-29
00884450022160One-Step™DOSC-4F-10T2026-07-29
00884450022184One-Step™DOSC-4F-7LT2026-07-29
00884450022306One-Step™DOSC-4F-7T2026-07-29
00884450022313One-Step™DOSC-5F-10LT2026-07-29
00884450022535One-Step™DOSC-5F-7LT2026-07-29
00884450022559One-Step™DOSC-5F-10S2026-07-29
00884450022566One-Step™DOSC-5F-7S2026-07-29
00884450022573One-Step™DOSC-4F-10L2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DRE2026-07-31
10884450708955Prelude®Merit Medical Systems, Inc.DRE2026-07-18
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00884450860342Merit S-MAK™Merit Medical Systems, Inc.DRE2026-06-25
00884450468340Merit MAK™Merit Medical Systems, Inc.DRE2026-06-23
10884450415358Prelude®Merit Medical Systems, Inc.DRE2026-05-28
04251244502768Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244502782Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244501983Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244501990Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502003Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502010Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502027Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502034Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502041Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502058Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502065Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502072Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502089Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502096Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502102Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502119Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502126Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502133Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502140Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502157Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502164Catapult Guide SheathContract Medical International GmbHDRE2023-09-01