Prelude Roadster™ PG8F45SX

GUDID 10884450532574

Merit Medical Systems, Inc.

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• Primary Device ID: 10884450532574
• NIH Device Record Key: f09a278e-b391-48ab-81fb-dc7647cf87b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelude Roadster™
• Version Model Number: 00884450532577
• Catalog Number: PG8F45SX
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450532577 [Primary]
GS1	10884450532574 [Package]; Contains: 00884450532577; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• GBX: CATHETER, IRRIGATION

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: 2024-03-20
• Device Publish Date: 2022-12-28

On-Brand Devices [Prelude Roadster™]

• 10884450531966: 00884450531969
• 10884450532307: 00884450532300
• 10884450532147: 00884450532140
• 10884450531706: 00884450531709
• 10884450531713: 00884450531716
• 10884450532543: 00884450532546
• 10884450531942: 00884450531945
• 10884450531737: 00884450531730
• 10884450532581: 00884450532584
• 10884450532567: 00884450532560
• 10884450532536: 00884450532539
• 10884450532321: 00884450532324
• 10884450532130: 00884450532133
• 10884450532161: 00884450532164
• 10884450532154: 00884450532157
• 10884450532314: 00884450532317
• 10884450557508: 00884450557501
• 10884450532550: 00884450532553
• 10884450532598: 00884450532591
• 10884450532062: 00884450532065
• 10884450531928: 00884450531921
• 10884450532512: 00884450532515
• 10884450532604: 00884450532607
• 10884450531911: 00884450531914
• 10884450532178: 00884450532171
• 10884450531959: 00884450531952
• 10884450770754: 00884450770757
• 10884450770785: 00884450770788
• 10884450770778: 00884450770771
• 10884450770761: 00884450770764
• 10884450532574: 00884450532577
• 10884450532529: 00884450532522
• 10884450532345: 00884450532348