Prelude Wave™ WAV6F11018NTPD-F

GUDID 20884450071131

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID20884450071131
NIH Device Record Key192b6e84-fe3f-40e0-a77f-0fd500a2d6cb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrelude Wave™
Version Model NumberInitial Release
Catalog NumberWAV6F11018NTPD-F
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS100884450071137 [Unit of Use]
GS110884450071134 [Primary]
GS120884450071131 [Package]
Contains: 10884450071134
Package: [4 Units]
In Commercial Distribution

FDA Product Code

DYBIntroducer, catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-04
Device Publish Date2025-07-26

On-Brand Devices [Prelude Wave™]

20884450072206Initial Release
20884450071131Initial Release
20884450068872Initial Release
20884450065444Initial Release

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