FDA.reportPublic FDA data

Prelude Roadster™

Primary DI
00884450838136
Brand
Prelude Roadster™
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
PG6F45R
Published
2026-07-31
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
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
DYBIntroducer, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450838133PackageGS15In Commercial Distribution
00884450838136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445083813310884450838133
00884450838136008844508381368844508381360884450838136

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
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00884450148228Merit Medical®Initial ReleaseK09-09226C2026-08-19
00884450428474Merit Medical®Initial ReleaseK10-04389A2026-08-19
00884450432365Merit Medical®Initial ReleaseK10-05106A2026-08-18
00884450476079CorVocet™BCORA1410S2026-08-18
00884450476093CorVocet™BCORA14152026-08-18
00884450838211Prelude Roadster™APG7F45SX2026-08-18
00884450457535C2 CryoBalloon™AFG-10402026-08-17
00884450458204DuraMax®BH7871030280312026-08-17
00884450531969Prelude Roadster™00884450531969PG6F45S2022-07-20
00884450122471Merit Medical®Initial ReleaseK08-01887B2026-08-14
00884450428245Merit Medical®Initial ReleaseK10-05700A2026-08-15
00884450467220Merit Medical®Initial ReleaseK09-05248N2026-08-14
00884450488775Merit Medical®Initial ReleaseK10T-04423Q2026-08-14
00884450488843Merit Medical®Initial ReleaseK12T-127422026-08-15
00884450110164Merit Disposal Depot™Initial ReleaseK10-00230D2026-08-07
00884450487402Merit Medical®Initial ReleaseK01-083682026-08-07
00884450500859Merit Medical®Initial ReleaseK09-10938D2026-08-08
00884450421994Merit Medical®Initial ReleaseK12-12513B2026-08-01
00884450447093Merit Medical®Initial ReleaseK09-02692J2026-08-01
00884450468951DuraMax®CH7871030282012026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-18
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012377R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012384R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00685447003328VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003335VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003342VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003359VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003366VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003373VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003380VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003397VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003403VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003410VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003427VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003434VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003441VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003458VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003465VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003472VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003489VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003496VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003502VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003519VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26
00685447003526VersaCross Transseptal SheathBaylis Médicale Cie IncDYB2019-06-26