Prelude Prestige™ PLP-1016/A

GUDID 00884450510292

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00884450510292
• NIH Device Record Key: 8a8afb79-e74b-4440-8156-feb289f0e778
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelude Prestige™
• Version Model Number: 10884450510299
• Catalog Number: PLP-1016/A
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 5
• 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
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450510292 [Unit of Use]
GS1	10884450510299 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-19
• Device Publish Date: 2021-03-11

On-Brand Devices [Prelude Prestige™]

• 00884450510162: 10884450510169
• 00884450510292: 10884450510299
• 00884450510636: 10884450510633
• 00884450510193: 10884450510190
• 00884450510612: 10884450510619
• 00884450510735: 10884450510732
• 00884450510575: 10884450510572
• 00884450510230: 10884450510237
• 00884450510247: 10884450510244
• 00884450510179: 10884450510176
• 00884450510131: 10884450510138
• 00884450510124: 10884450510121
• 00884450510711: 10884450510718
• 00884450510582: 10884450510589
• 00884450511213: 10884450511210
• 00884450511138: 10884450511135
• 00884450511176: 10884450511173
• 00884450511190: 10884450511197
• 00884450511121: 10884450511128
• 00884450511206: 10884450511203
• 00884450511152: 10884450511159
• 00884450510261: 10884450510268
• 00884450510216: 10884450510213
• 00884450511145: 10884450511142
• 00884450511169: 10884450511166
• 00884450510599: 10884450510596
• 00884450511183: 10884450511180
• 00884450510698: 10884450510695
• 00884450510629: 10884450510626
• 00884450510728: 10884450510725
• 00884450511114: 10884450511111
• 00884450510551: 10884450510558
• 00884450510513: 10884450510510
• 00884450510315: 10884450510312
• 00884450510223: 10884450510220
• 00884450510186: 10884450510183
• 00884450510506: 10884450510503
• 00884450510674: 10884450510671
• 00884450510520: 10884450510527
• 00884450510681: 10884450510688
• 00884450510322: 10884450510329
• 00884450510209: A
• 00884450510278: 10884450510275
• 00884450510704: A
• 00884450510544: A
• 00884450510308: A
• 00884450510650: A