basixTOUCH™ IN8353

GUDID 20884450621374

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 20884450621374
• NIH Device Record Key: 137d7998-c4ae-4253-a82e-593d8e7cb210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: basixTOUCH™
• Version Model Number: C
• Catalog Number: IN8353
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450621370 [Primary]
GS1	10884450621377 [Package]; Contains: 00884450621370; Package: [5 Units]; In Commercial Distribution
GS1	20884450621374 [Package]; Contains: 10884450621377; Package: [2 Units]; In Commercial Distribution

FDA Product Code

• PTM: Syringe, Balloon Inflation, Exempt

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: 2025-01-23
• Device Publish Date: 2025-01-15

On-Brand Devices [basixTOUCH™]

• 10884450298128: 00884450298121
• 10884450292973: 00884450292976
• 10884450292966: 00884450292969
• 10884450292959: 00884450292952
• 20884450292949: 00884450292945
• 10884450252595: 00884450252598
• 10884450203214: 00884450203217
• 20884450168213: 00884450168219
• 20884450168190: 00884450168196
• 20884450168183: 00884450168189
• 10884450166489: 00884450166482
• 20884450116856: 00884450116852
• 10884450115883: 00884450115886
• 20884450114173: 00884450114179
• 10884450108434: 00884450108437
• 20884450108349: 00884450108345
• 20884450363991: 00884450363997
• 20884450297395: 00884450297391
• 20884450447844: 00884450447840
• 10884450447854: 00884450447857
• 20884450627109: 00884450627105
• 20884450621305: 00884450621301
• 20884450621053: 00884450621059
• 10884450621032: 00884450621035
• 10884450621414: 00884450621417
• 20884450621329: 00884450621325
• 20884450621428: 00884450621424
• 10884450641948: 00884450641941
• 10884450621346: C
• 10884450621391: C
• 20884450621374: C