BIG60™ ENDO-AN6012

GUDID 10884450860370

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 10884450860370
• NIH Device Record Key: 299170ae-e7c0-4902-87c3-d2961db78e1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIG60™
• Version Model Number: T
• Catalog Number: ENDO-AN6012
• 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	00884450860373 [Primary]
GS1	10884450860370 [Package]; Contains: 00884450860373; Package: [5 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: 2025-06-09
• Device Publish Date: 2025-05-31

On-Brand Devices [BIG60™]

• 10884450088743: 00884450088746
• 10884450860370: T