FDA.report

Prelude® PRO

Primary DI
20884450707337
Brand
Prelude® PRO
Company
Merit Medical Systems, Inc.
Model
F
Catalog number
PRO-5F-11-035MT
Published
2024-08-21
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

Related Records

Product Codes

CodeName
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications

CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884450707337PackageGS14In Commercial Distribution
10884450707330PrimaryGS10
00884450707333Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445070733720884450707337
1088445070733010884450707330
00884450707333008844507073338844507073330884450707333

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

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 DIBrandModelCatalogPublished
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
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10884450845223Merit Medical®Merit Medical Systems, Inc.DRE2026-03-24
10884450441784SteadySheath®Merit Medical Systems, Inc.DRE2026-03-21
10884450441616Evolution® RLMerit Medical Systems, Inc.DRE2026-03-11
10884450441746Evolution® RLMerit Medical Systems, Inc.DRE2026-03-11
10884450441753Evolution® RLMerit Medical Systems, Inc.DRE2026-03-11
10884450441623Evolution® RLMerit Medical Systems, Inc.DRE2026-03-10
10884450441777SteadySheath®Merit Medical Systems, Inc.DRE2026-03-06
10884450441791SteadySheath®Merit Medical Systems, Inc.DRE2026-03-06
10884450441807SteadySheath® ShortieMerit Medical Systems, Inc.DRE2026-03-06
10884450441760Evolution® Shortie RLMerit Medical Systems, Inc.DRE2026-03-05
20884450707795Prelude®Merit Medical Systems, Inc.DRE2026-02-14
08033178019545PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019552PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019576PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019583PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019590PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
20884450706798Prelude®Merit Medical Systems, Inc.DRE2026-01-16
20884450708945Prelude®Merit Medical Systems, Inc.DRE2026-01-16
10884450847333Merit MAK™Merit Medical Systems, Inc.DRE2025-12-05
10884521811188RitusMozarc Medical US LLCDRE2025-11-27
10884450587185Merit PAK™Merit Medical Systems, Inc.DRE2025-09-05
20884450707177Prelude ACT™Merit Medical Systems, Inc.DRE2025-09-04
20884450708976Prelude®Merit Medical Systems, Inc.DRE2025-08-26
10884450846787Merit MAK Gold™Merit Medical Systems, Inc.DRE2025-08-15
20884450614628Prelude®Merit Medical Systems, Inc.DRE2025-08-14
00763000925116FlexCath Cross™ Transseptal SolutionMEDTRONIC, INC.DRE2025-08-10
00763000925130FlexCath Cross™ Transseptal SolutionMEDTRONIC, INC.DRE2025-08-10
10884450847265Merit MAK Gold™Merit Medical Systems, Inc.DRE2025-08-05
20884450076730Prelude® PROMerit Medical Systems, Inc.DRE2025-07-24
10884450847340Merit S-MAK™Merit Medical Systems, Inc.DRE2025-07-16