Prelude IDeal™ PID6F11018SC/A

GUDID 20884450381827

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20884450381827
• NIH Device Record Key: 1d453c98-086c-48a7-b32f-805d3d26356f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelude IDeal™
• Version Model Number: 10884450381820
• Catalog Number: PID6F11018SC/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
• 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	00884450381823 [Unit of Use]
GS1	10884450381820 [Primary]
GS1	20884450381827 [Package]; Contains: 10884450381820; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173750

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: 2020-05-11
• Device Publish Date: 2020-05-01

On-Brand Devices [Prelude IDeal™]

• 20884450317543: 10884450317546
• 20884450317741: 10884450317744
• 20884450335035: 10884450335038
• 20884450335028: 10884450335021
• 20884450335004: 10884450335007
• 20884450334991: 10884450334994
• 20884450320468: 10884450320461
• 20884450320451: 10884450320454
• 20884450317727: 10884450317720
• 20884450317710: 10884450317713
• 20884450317703: 10884450317706
• 20884450317673: 10884450317676
• 20884450317628: 10884450317621
• 20884450317611: 10884450317614
• 20884450317604: 10884450317607
• 20884450317598: 10884450317591
• 20884450317581: 10884450317584
• 20884450317574: 10884450317577
• 20884450317529: 10884450317522
• 20884450317512: 10884450317515
• 20884450317475: 10884450317478
• 20884450317451: 10884450317454
• 20884450317390: 10884450317393
• 20884450317383: 10884450317386
• 20884450317376: 10884450317379
• 20884450317369: 10884450317362
• 20884450317352: 10884450317355
• 20884450317338: 10884450317331
• 20884450317321: 10884450317324
• 20884450317307: 10884450317300
• 20884450317277: 10884450317270
• 20884450317246: 10884450317249
• 20884450317185: 10884450317188
• 20884450317178: 10884450317171
• 20884450317130: 10884450317133
• 20884450317123: 10884450317126
• 20884450317116: 10884450317119
• 20884450317093: 10884450317096
• 20884450317079: 10884450317072
• 20884450317062: 10884450317065
• 20884450317055: 10884450317058
• 20884450317048: 10884450317041
• 20884450317031: 10884450317034
• 20884450335011: 10884450335014
• 20884450334984: 10884450334987
• 20884450317536: 10884450317539
• 20884450317482: 10884450317485
• 20884450317468: 10884450317461
• 20884450317406: 10884450317409
• 20884450317215: 10884450317218