Prelude Prestige™ PLPS-1016

GUDID 10884450313883

Merit Medical

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10884450313883
• NIH Device Record Key: 7061d35c-4754-41bd-b4ef-58f1c81884b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelude Prestige™
• Version Model Number: 10884450313883
• Catalog Number: PLPS-1016
• Company DUNS: 065673912
• Company Name: Merit Medical
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450313886 [Unit of Use]
GS1	10884450313883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172117

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-07
• Device Publish Date: 2019-04-23

On-Brand Devices [Prelude Prestige™]

• 10884450313883: 10884450313883
• 10884450313517: 10884450313517
• 10884450313487: 10884450313487
• 10884450313470: 10884450313470
• 10884450313449: 10884450313449
• 10884450313425: 10884450313425
• 10884450313401: 10884450313401
• 10884450313647: 10884450313647
• 10884450313463: 10884450313463
• 10884450313456: 10884450313456
• 10884450313432: 10884450313432
• 10884450313418: 10884450313418
• 10884450313395: 10884450313395
• 10884450313388: 10884450313388
• 10884450313326: 10884450313326
• 10884450313319: 10884450313319
• 10884450313548: 10884450313548
• 10884450313845: 10884450313845
• 10884450313494: 10884450313494
• 10884450313630: 10884450313630
• 10884450313616: 10884450313616
• 10884450313500: 10884450313500
• 00884450313862: 10884450313869
• 00884450313824: 10884450313821
• 00884450313657: 10884450313654
• 10884450313913: 10884450313913
• 10884450313784: 10884450313784
• 10884450313753: 10884450313753
• 10884450313722: 10884450313722
• 10884450313692: 10884450313692
• 10884450313685: 10884450313685
• 10884450313661: 10884450313661
• 00884450313855: 10884450313852
• 00884450313831: 10884450313838
• 00884450313800: 10884450313807
• 00884450313732: 10884450313739
• 00884450313794: 10884450313791
• 00884450313763: 10884450313760