Advocate™ A18050250130/A

GUDID 10884450302504

Merit Medical Systems, Inc.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 10884450302504
• NIH Device Record Key: 90575515-47a7-43fd-be5e-64ffcb6dd12f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advocate™
• Version Model Number: 00884450302507
• Catalog Number: A18050250130/A
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450302507 [Primary]
GS1	10884450302504 [Package]; Contains: 00884450302507; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173621

FDA Product Code

• LIT: Catheter, angioplasty, peripheral, transluminal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-08-09
• Device Publish Date: 2019-06-24

On-Brand Devices [Advocate™]

• 10884450300883: 00884450300886
• 10884450302030: 00884450302033
• 10884450301903: 00884450301906
• 10884450297749: 00884450297742
• 10884450301811: 00884450301814
• 10884450301774: 00884450301777
• 10884450301248: 00884450301241
• 10884450303983: 00884450303986
• 10884450302528: 00884450302521
• 10884450302429: 00884450302422
• 10884450300944: 00884450300947
• 10884450304638: 00884450304631
• 10884450301224: 00884450301227
• 10884450377359: 00884450377352
• 10884450303709: 00884450303702
• 10884450303013: 00884450303016
• 10884450302504: 00884450302507
• 10884450302221: 00884450302224
• 10884450300432: 00884450300435
• 10884450301750: 00884450301753
• 10884450304485: 00884450304488
• 10884450301156: 00884450301159
• 10884450304461: 00884450304464
• 10884450303419: 00884450303412
• 10884450301804: 00884450301807
• 10884450303716: 00884450303719
• 10884450301910: 00884450301913
• 10884450300371: 00884450300374
• 10884450300203: 00884450300206
• 10884450304782: 00884450304785
• 10884450303600: 00884450303603
• 10884450303532: 00884450303535
• 10884450304195: 00884450304198
• 10884450300494: 00884450300497
• 10884450377847: 00884450377840
• 10884450305277: 00884450305270
• 10884450301149: 00884450301142
• 10884450377410: 00884450377413
• 10884450305314: 00884450305317
• 10884450302382: 00884450302385
• 10884450302054: 00884450302057
• 10884450377649: 00884450377642
• 10884450377540: 00884450377543
• 10884450303846: 00884450303849
• 10884450301279: 00884450301272
• 10884450378424: 00884450378427
• 10884450303297: 00884450303290
• 10884450303020: 00884450303023
• 10884450300456: 00884450300459
• 10884450300357: 00884450300350