Prelude®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: Prelude® FDA UDI
Generic Name: Vascular catheter introduction set, nonimplantable FDA UDI
Model / Reference: 10884450614089 FDA UDI

Identifiers

Catalog Number: PSI-7F-11-018/D FDA UDI
Primary DI / UDI-DI: 10884450614089 FDA UDI
FDA Product Code: DRE FDA UDI
GMDN Term: Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1310 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Vascular catheter introduction set, nonimplantable Vascular dilator, single-use

Precede vascular access with the Prelude device, a single-use non-implantable vascular catheter introduction set designed for safe and effective percutaneous procedures. This sterile, hand-held instrument is used to unblock or enlarge blood vessels during surgical interventions.

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Also classified as Vascular dilator, single-use.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Merit Medical Systems, Inc.

Sources (1)

FDA UDI f109284f-347c-4ebd-be47-01910ab46df4 34 fields · synced Jun 27, 2026