Prelude PRO™ PRO-6F-11-035MT/C

GUDID 20884450331112

Merit Medical Systems, Inc.

Vascular dilator, single-use

• Primary Device ID: 20884450331112
• NIH Device Record Key: 2b48882c-c660-45dd-9920-b4ff0bd5edfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelude PRO™
• Version Model Number: 10884450331115
• Catalog Number: PRO-6F-11-035MT/C
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450331118 [Unit of Use]
GS1	10884450331115 [Primary]
GS1	20884450331112 [Package]; Contains: 10884450331115; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073035

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

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: 2019-11-04
• Device Publish Date: 2019-10-25

On-Brand Devices [Prelude PRO™]

• 20884450332010: 10884450332013
• 20884450331181: 10884450331184
• 20884450331174: 10884450331177
• 20884450331167: 10884450331160
• 20884450331143: 10884450331146
• 20884450330672: 10884450330675
• 20884450330634: 10884450330637
• 20884450330603: 10884450330606
• 20884450330498: 10884450330491
• 20884450330443: 10884450330446
• 20884450330436: 10884450330439
• 20884450330429: 10884450330422
• 20884450330412: 10884450330415
• 20884450330399: 10884450330392
• 20884450330382: 10884450330385
• 20884450330375: 10884450330378
• 20884450330351: 10884450330354
• 20884450330344: 10884450330347
• 20884450330337: 10884450330330
• 20884450330313: 10884450330316
• 20884450330306: 10884450330309
• 20884450330283: 10884450330286
• 20884450292413: 10884450292416
• 20884450035621: 10884450035624
• 20884450011809: 10884450011802
• 20884450011793: 10884450011796
• 20884450011786: 10884450011789
• 20884450011779: 10884450011772
• 20884450011762: 10884450011765
• 20884450011755: 10884450011758
• 20884450011748: 10884450011741
• 20884450011731: 10884450011734
• 20884450331112: 10884450331115
• 20884450602939: 10884450602932
• 20884450331198: 10884450331191
• 20884450331150: 10884450331153
• 20884450331136: 10884450331139
• 20884450331105: 10884450331108
• 20884450330658: 10884450330651
• 20884450011519: 10884450011512
• 20884450010666: 10884450010669
• 20884450010642: 10884450010645
• 20884450010635: 10884450010638
• 20884450009837: 10884450009830
• 20884450009820: 10884450009823
• 20884450009813: 10884450009816
• 20884450009776: 10884450009779
• 20884450009769: 10884450009762
• 20884450009752: 10884450009755
• 20884450009707: 10884450009700